myth busters - Modern medicine
Cataract Refractive Surgery
MYTH BUSTERS
Published as a
promotional supplement to
SEPTEMBER 2015
PHOTO CREDIT: PAUL WHITTEN/SCIENCE SOURCE
Optimizing Procedures with the LenSx® Laser
LenSx
®
LASER
FUNDING AND CONTENT
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Published as a
promotional supplement to
SEPTEMBER 2015
Cataract Refractive Surgery
MYTH BUSTERS
Optimizing Procedures with the LenSx® Laser
FUNDING AND CONTENT
ASSISTANCE PROVIDED BY
Dr. Berdahl is an Alcon
consultant, speaker, and
clinical investigator.
Dr. Davidson is an Alcon
consultant, speaker, and
clinical investigator.
Dr. Scoper is an Alcon
consultant, speaker, and
clinical investigator.
LenSx
®
LASER
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2
Cataract Refractive Surgery MYTH BUSTERS: Optimizing Procedures with the LenSx® Laser
MYTH:
THE LENSX® LASER IS NEITHER
EFFECTIVE NOR EFFICIENT
Stephen V. Scoper, MD, Vice President,
Virginia Eye Consultants, Norfolk, VA
When I first acquired a LenSx® Laser in the summer
of 2011, I was interested in two things: first, would I
get better results with the LenSx® Laser than a manual
procedure, and second, would the LenSx® Laser be
efficient to incorporate within my busy practice?
In a study by Filkorn et al, 41.6 percent of eyes
that underwent laser refractive cataract surgery with
the LenSx® Laser (n=77) were within ±0.25 D of target
refraction compared to 28.1 percent of eyes that under­
went conventional cataract surgery with phacoemulsi­
fication (n=57). More patients in the LenSx® Laser group
were also within ±0.5 D of target refraction.1
Of the approximately 2,400 cataract surgeries I perform annually, I use the LenSx® Laser in 57 percent. I’m
able to use the LenSx® Laser with confidence based on
prior results, and both my patients and staff know that
my procedures are better due to its use.
But what about efficiency? Do I see more, fewer, or
the same number of patients during the day by switching
to the LenSx® Laser?
When I book a patient for use of the LenSx® Laser,
I realize that I am actually performing two procedures
rather than one, and being reimbursed for each procedure
separately. So while I may perform 30 cataract surgeries in
a day, assuming that I use the LenSx® Laser on 50 percent
Figure 1: Dr. Stephen Scoper docking a patient using the simple 1-piece
SoftFit™ Patient Interface and control joystick.
of those patients, I am performing 45 actual procedures.
With the LenSx® Laser, I find that I am typically in and
out of the laser room in 2 minutes or less (Figure 1). In
addition, the LenSx® Laser usually allows me to save time
in the operating room thanks to the capsulotomy and
fragmentation I have created.
Effectiveness and Efficiency
of the OCT
When I initially look at LenSx® Laser OCT, the first thing
I want to know is whether the lens is tilted, which can
be determined by examining the imaging of the anterior
capsule (Figure 2). It’s important for surgeons to under­
Cornea
Anterior Chamber
Figure 2: LenSx® Laser’s HD
Circle Scan provides a complete
360-degree view of the eye
that is “unwrapped” to a create
a linear image.
Anterior Capsule
(Contour Guidance)
Please see page 11 of this supplement for Important Product Information about Alcon products.
Published as a promotional supplement to Ophthalmology Times®
3
type of fragmentation pattern that they want (chop, cylinder,
hybrid, grid, or grid with spokes), and the OCT will
confirm the landmarks. With the latest software update,
the OCT measures the periphery of the cornea for arcuate
incisions. I rarely find that I make a manual correction
(Figure 3, part of OCT imaging).
Preparing the Patient
for Cataract Surgery
Figure 3: LenSx® Laser’s HD OCT produces full anterior segment images to a
depth of 8.5 mm in a single scan which takes only a few seconds.
stand that when they look at this linear anterior capsule,
what they are really looking at is a circle that has been
unwrapped. At each end of that capsule, the right or left
ends are the same – they just connect to each other. The
planned circular capsulotomy is “unwrapped” into a
straight line.
I like to make my cut about 300 µm above and below
the capsule. It’s important to make sure your cuts are
both above and below the entire capsule to avoid tags.
The second thing I look at on the OCT is the ablation
pattern for the lens itself. I like to lower the ablation
pattern posteriorly as deeply as I can. I find that the
deeper I go with either the hybrid or grid pattern, the
better I’m able to sculpt down in the OR. I typically
perform a two-plane incision as my primary corneal
incision that mimics my blade incision. I tend to go
in steeply so that the cornea isn’t distorted.
With the LenSx® Laser OCT, surgeons can choose any
Figure 4: Dr. Stephen Scoper performing cataract refractive surgery with the
LenSx® Laser (Images courtesy Dr. Stephen V. Scoper).
4
It’s important for surgeons to be in complete control
of the laser suite and operating rooms so that their
staff is clear on preparations that need to be made before
the start of every procedure. With every patient, my
staff reviews the step-by-step process of surgery, reminding the patient, for instance, to look directly at
the center of the ring of six white lights while they
are under the LenSx® Laser. Of course, I reinforce
each step with the patient when I walk into the room,
but it’s helpful that I am simply a reminder instead
of the initial teacher.
When I walk into the laser suite, my staff already
has the patient positioned under the LenSx® Laser
(Figure 4). The iris plane is planar to the floor. The
patient’s chin and head are properly positioned at the
correct distance from the patient interface. I put in
the lid speculum as I’m talking to the patient.
I then ask the patient to fixate on the six white
lights that form a ring. Once I see a little bit of
meniscus, I engage the LenSx® Laser suction. At that
same moment, I tell the patient that things should
be dark and grey for them and that the lights have
gone out. If they are not preparing for that, I find
that they may be surprised when the lights disappear.
Applanation happens in a couple of seconds.
After I have docked the patient, the OCT confirms
the pre-determined landmarks. There are times
when I’ll make some minor tweaks, but this does
not occur frequently. As I’m reviewing the settings,
I maintain a constant dialogue with the patient
to keep them informed of our progress (“Less than
1 and a half minutes to go,” etc.). When I activate
the laser, I tell the patient that there are less than 30
seconds to go, and count down every 5 seconds. And
then once we’re done, I remind the patient to remain
very still as we raise the laser, and then reassure them
that “the laser went great!”
Cataract Refractive Surgery MYTH BUSTERS: Optimizing Procedures with the LenSx® Laser
Cataract patients can sometimes be nervous when
they are wheeled under the laser, and it is incumbent
upon surgeons and our teams to provide positive words
of affirmation. Maintaining a calm dialogue during the
entire procedure can go a long way toward reassuring
your patients. The best anesthesia is “verbal anesthesia.”
Conclusion
Use of the LenSx® Laser leads to a high rate of success
in hitting target refraction goals, as well as saving time
in the operating room. With multiple fragmentation
patterns available to surgeons, along with a recent software
update, manual corrections are rarely needed when using
the OCT to determine surgical landmarks.
Reference
1. Filkorn T, Kovács I, Takács A, Horváth E, Knorz MC, Nagy ZZ. Com­
parison of IOL power calculation and refractive outcome after laser
refractive cataract surgery with a femtosecond laser versus conven­
tional phacoemulsification. J Refract Surg. 2012;28(8):540-4.
PRACTICE PEARLS
reserve the grid pattern for 4+ nuclear
in the laser room, and she makes sure
When I first got a LenSx Laser, the
sclerotic lenses. When I select a hybrid
the LenSx® Laser is always properly
steepest learning curve wasn’t in regards
pattern, I crack each quadrant before
calibrated. I have complete confidence
to use of the actual laser itself but instead
phacoemulsification. Each quadrant
that, as soon as I set foot into the room
the resulting differences in the OR. My
typically comes forward easily in a matter
for each patient, everything is set exactly
first step is to open the arcuate incisions
of seconds. The grid pattern is particularly
the way it should be.
and then go into my secondary incision.
efficient with a dense cataract.
OR Technique
®
When patients thank me for restoring
One of the techniques I initially needed
their vision, I encourage them to thank the
I always touch the capsulotomy in two
to learn after I obtained the LenSx® Laser
entire staff for the difference we are making
or three places to confirm that it is
was the best procedure to remove the
in their life. I tell them to thank my tech, who
free-floating. This is especially important
cortex. I use a sweeping counter-clockwise
did the calculations, who helped select the
when using a grid pattern if the edges
motion under the edge of the capsulotomy
right implant, and made a profound impact
of the capsulotomy are difficult to
to remove the cortex.
on the success of the surgery.
during the LenSx Laser procedure.
Appreciating Your Staff
good practical sense as well because every
Anterior capsule tears are also rare with
For many of our patients, we are the
time that tech gets a thank you or a hug,
use of a femtosecond laser – in a 2014
heroes, the ones who are responsible
she’s going to try even harder the next
published case series of 1,500 eyes, there
for improving and possibly saving their
time to give every patient the same chance
were less than 1 percent anterior capsule
vision. It’s important for team morale
to have their vision restored.
tears (0.31 percent), posterior capsule
to make sure to spread the kudos widely
tears (0.31 percent) and posterior lens
amongst your staff. All surgeons know
Reference
dislocation (0 percent) following an
that they can’t do this job alone. I have
initial learning curve of 200 cases.
one tech whose job is to essentially
1. Roberts TV, Lawless M, Bali SJ, Hodge C,
Sutton G. Surgical outcomes and safety of
femtosecond laser cataract surgery: a pro­
spective study of 1500 consecutive cases.
Ophthalmology. 2013;120(2):227-33.
After opening the primary incision,
It’s not just a nice gesture, but it makes
visualize. These days, I rarely see a tag
®
1
When I use the LenSx® Laser, I typically
“own” the LenSx® Laser. She makes sure
perform a hybrid four quadrant pattern and
the humidity and temperature are right
Please see page 11 of this supplement for Important Product Information about Alcon products.
Published as a promotional supplement to Ophthalmology Times®
5
MYTH
LENSX® LASER’S INTERFACE
IS BURDENSOME TO USE
John Berdahl, MD, Vance Thompson Vision,
Sioux Falls, SD
One of the primary challenges when evaluating the pros
and cons of high-cost capital equipment such as a femto­
second laser is that few people have experience using more
than one platform. It’s like changing from a PC to a Mac
– initially, you scratch your head and wonder “Why did
they put that over there?” However, you are soon able to
gain a greater appreciation for both platforms and their
specific nuances.
In talking to surgical colleagues who utilize a variety of
laser platforms, while there are nuances to each, the user
interfaces are all operator-friendly. As one of the earliest
adopters, the majority of my experience is with the LenSx®
Laser. There are four things in particular I like about the
LenSx® Laser user interface (Figure 5):
1.It is very clear what you are doing at every step
in the procedure: Especially when coupled with the
Verion™ Image Guided System, there are many steps
done automatically for you. For instance, there is no
data entry required for the surgeon or staff, eliminating the odds of a transcription error. In addition,
a number of key anatomic landmarks on the eye are
automatically recognized, which allows for preplace­
ment of the incision, arcuates, capsulotomy, and lens
fragmentation.1
Figure 5: LenSx® Laser’s graphic user interface during arcuate incision
planning.
6
2.Making changes to the preplaced settings is simple:
Once surgical landmarks are preliminarily set, the
operator has the ability to either verify the settings or
make changes based upon personal preferences or
observations of the optical coherence tomography
(OCT) at the touch of a button.1
3.The OCT imagery does an excellent job of identifying
cataract thickness: The LenSx® Laser OCT results help
me understand how deep I can go with my phacoemul­
sification tip and prevent me from going too deep on a
dense, yet thin, cataract.
4. Completing step-by-step procedures happens quickly:
The LenSx® Laser user interface screen is extremely
intuitive, making it easy to progress through the
preparation and verification processes quickly.
Historical Improvements
After consultation with one of Alcon’s clinical specialists,
the energy and spot separations for my incisions on my
machine were decreased. It dramatically improved the
Figure 6: Dr. John Berdahl performing cataract refractive surgery with the
LenSx® Laser (Image courtesy Dr. John Berdahl).
Cataract Refractive Surgery MYTH BUSTERS: Optimizing Procedures with the LenSx® Laser
quality of the incisions to match anything I might be able
to create manually.
From a hardware perspective, the biggest improvement
to the LenSx® Laser since I started using it was the
introduction of the LenSx® Laser’s SoftFit™ Patient
Interface. This interface allows surgeons to use a soft
contact lens that closely matches the corneal curvature
of the eye. This interface has allowed me to get better
centration, better and faster docking, and more consistent capsulotomies and incisions. One study of the use
PRACTICE PEARLS
Sealing Incisions
When a patient arrives in our office for a
one of the most significant time-limiting
Once my capsulotomy is complete with
scheduled surgery, they initially sit down
factors in the OR, making protocol changes
the LenSx Laser, I stromally hydrate the
in the chair, which is then unfolded into
such as this have helped our office become
roof of the incision as opposed to the
a bed. We then wheel the patient under-
more efficient.
corners of the incision. This allows for
neath the laser and then, once that
a tri-planar incision. The LenSx® Laser
procedure is complete, they are wheeled
Sublingual Anesthesia
creates a little shelf internally that can
directly into the surgical theater. Once
We don’t start IVs anymore. Instead,
be hydrated and then sealed. A 2014
they initially sit down in the chair at the
we use sublingual anesthesia, which
study by Mastropasqua et al showed
start of the visit, the patient never has
helps relax patients before they are
that, compared to manual clear corneal
to get up. Not only is that a time saver,
wheeled under the laser. Patients love
incision, use of the LenSx Laser results
but it also avoids potential falls and
avoiding an anesthesia needle, and we
in less endothelial and epithelial gaping,
provides a better patient experience.
get the added benefit of having them
®
®
less tense under the laser.
as well as less endothe­lial misalignment
at multiple time points. In this study,
Cardiac Monitors
endothelial cell loss was also significantly
Our cardiac monitors are attached to
Reference
reduced in the LenSx Laser group.
the bed so that patients are hooked up
1. Mastropasqua L, Toto L, Mastropasqua A,
et al. Femtosecond laser versus manual
clear corneal incision in cataract surgery.
J Refract Surg. 2014;30(1):27-33.
®
1
in pre-op and time isn’t wasted in the
Optimizing Your Machine
operating room. Since turnover time is
Each laser, regardless of manufacturer,
should be optimized for the individual
user. Typically, manufacturer representatives can help to customize settings for
the individual surgeon (my standard settings
are shown in Figure 7). Yet while settings
may not be identically transferable across
machines, it is important to recognize if you
happen to work in multiple surgical centers
what the general principles are that drive
each platform. Laser settings are more
transferable than manual tech­niques you
may watch on video or that are based
on a conversation with another surgeon.
Non-Fixed Beds
We have chairs that convert into beds that
we use for all of our cataract patients.
Figure 7. Default LenSx® Laser incision settings (Image courtesy Dr. John Berdahl).
Please see page 11 of this supplement for Important Product Information about Alcon products.
Published as a promotional supplement to Ophthalmology Times®
7
of the LenSx® Laser after the introduction of the LenSx®
Laser’s SoftFit™ Patient Interface found no cases of anterior
capsule tear or corneal fold, and no additional required
applanation attempts.2
I have had many of my laser-assisted surgeries video­
taped since I obtained the LenSx® Laser in 2011. When
I first began, it took me between 4 and 5 minutes to
perform most of my surgeries. With more experience
and thanks to several software updates that have been
implemented, today I am usually in and out of the room
in about 2 minutes. Cumulatively over days and weeks,
this time saved can have a significant impact on patient
flow. Especially when I’m only operating out of two
rooms, I’m able to go back and forth from the LenSx®
Laser room to the surgical suite without any waiting
(Figure 6) – by the time the staff prepares each room
for the next patient, I’m ready to go. If I am operating
out of 1 room, there is no loss of efficiency either.
It is vital that surgeons, regardless of the laser platform
they use, coordinate and train an advanced tech team
to minimize the time needed for each procedure and help
maximize patient comfort. Once I enter the room, my
patients are already positioned under the laser. We recheck
everything, enter in the specific laser parameters (for us,
these are imported directly from the Verion™ Image
Guided System), and then we dock.
References
1. Makari S, Potvin R. Cataract surgery and the LenSx femtosecond laser
system – 2015 update. US Ophthalmic Review. 2015;8(1):10-13.
2. Mayer WJ, Klaproth OK, Ostovic M, et al., Femtosecond laser assisted
lens surgery depending on interface design and laser pulse energy:
Results of the first 200 cases. Ophthalmologe. 2014;111:1172–7.
Considerations When Exploring
the Purchase of a Femtosecond
Laser
For those practices considering purchase of a femtosecond
laser, here are three questions you might want to consider:
1. Will the laser deliver the results you want and expect?
2. How is the incorporation of the laser into your practice going
to impact a surgical day?
3. H
ow much post-purchase technical support can you expect
to receive?
8
MYTH
LENSX® LASER DOES NOT
FRAGMENT THE NUCLEUS WELL
John Davidson, MD, is in private practice in
Ventura, CA, and Assistant Clinical Professor,
Stein Eye Institute, UCLA, Los Angeles, CA.
The LenSx® Laser with a SoftFit™ Patient Interface
possesses significant flexibility with regard to types of
lens fragmentation patterns offered and amount of laser
energy delivered. Because the LenSx® Laser fragments
the lens with laser energy, surgeons can utilize reduced
amounts of ultrasound power, minimizing risks to the
inside of the eye, which include injury to the corneal
endothelial cell layer and iris. The logic is simple – the
less ultrasound energy used, the fewer post-op corneal
edema and intraocular inflammation cases that need
to be addressed as a result.1
SoftFit™ Patient Interface
With the SoftFit™ Patient Interface, complete capsulotomies
are the rule, and lens fragmentation energy settings are
reduced, without the need for a multi-piece liquid interface.
Personal Experience
Ever since we acquired our first LenSx® Laser in May
2013, and then our second in November 2013, I have used
a combination of chop and cylinder lens fragmen­tation
patterns. I began using the grid pattern when it became
available last year with the software upgrade version 2.23.
The flexibility of the LenSx® Laser frag­mentation patterns
allows me to customize my approach to each case (Figure 8).
Combined Chop and Cylinder Patterns
The chop pattern, which can be used with either 1, 2 or 3
chops, can divide the nucleus into 2, 4 or 6 sections. The
cylinder pattern can create concentric cylindrical cuts
with an outer diameter adjustable from between 2.5 to
6.0 mm. The chops and cylinders can be used alone
or in combination to form a pattern that resembles a
symmetrical spider web.
The grid pattern efficiently divides the nucleus into
square sections. With the LenSx® Laser, surgeons have
the versatility to make squares as small as 200x200 µm
Cataract Refractive Surgery MYTH BUSTERS: Optimizing Procedures with the LenSx® Laser
A
B
C
Figure 8: Several LenSx® Laser fragmentation patterns: Grid (A), Hybrid (combination of chop and cylinder) (B), and Chop (C).
and as large as 500x500 µm. The square sections can be
long in the anterior-posterior direction, like French fries,
or can be further sliced with horizontal cuts across their
length into halves or thirds to maximize laser efficiency
and minimize the need for ultrasound.
With the grid pattern, optional spokes (either 4 or 8)
can be added that further facilitate peripheral propagation
of nuclear chopping.
Fragmentation Pearls
While I tend to use the grid pattern in the majority of
my cases, in some patients, I prefer to use a combined
chop and cylinder lens fragmentation pattern. The chops
fragment the lens into 6 easily removable pie-shaped
sections, and the cylinders concentrate on the core of
the nucleus. The chop diameter is set to the maximum
6.0 mm diameter and can be reduced on-the-fly for
smaller pupils. I typically adjust the number and outer
diameter of the cylinders based on nuclear density, from
0-to-8 cylinders and 2.5 to 4.5 mm outer diameter. This
pattern avoids leaving a bowl of outer nucleus.
When using the chop and cylinder pattern, I prefer to
keep the cylinders small so that I have mid-peripheral
tissue firm enough to easily impale with the phaco­
emulsification tip and chopper to propagate the chops
peri­pherally. Studies have shown that mean effective
phacoemulsification time is significantly lower when
using the LenSx® Laser vs. complete cataract removal
performed with phacoemulsification only.2 A study
among resident and fellow trainees also showed that
the use of the LenSx® Laser resulted in less mean irri-
gation fluid use and cumulative dissipated energy
compared to manual cases without use of laser.3
Case Examples
Walking through a few of my recent challenging cases
may be the best way to demonstrate the versatility
of the LenSx® Laser lens fragmentation patterns.
I recently had a 91-year-old patient with a grade 5/6
hard nucleus, shallow anterior chamber, pseudoexfoliation
and, fortunately, a widely dilating pupil. My primary concern
was safety, especially in getting the last fragment out of the
eye in the presence of a floppy posterior capsule. Using the
combined chop and cylinder pattern, I focused on producing
6 well-divided segments. The zonules were a bit loose, but
the Centurion® Vision System provided active fluidics that
helped keep the posterior capsule back and maintained
control of the anterior chamber environment. The segments
were safely removed with no remaining plate or cortex.
Another recent case involved a 68-year-old patient who
sustained blunt force trauma to the eye as a teenager. This
patient had a unilateral cataract with a dense nucleus and a
small pupil. The grid pattern delivered sufficient energy to
the core of the nucleus, along with the flexibility of on-the-fly
reduction in the diameter of the treatment to barely within
the pupillary border, resulting in a CDE of less than 5 seconds.
Conclusion
LenSx® Laser’s SoftFit™ Patient Interface has the versatility
that surgeons need to customize their approach to lens
fragmentation for a wide variety of situations without the
need for a liquid interface.
Please see page 11 of this supplement for Important Product Information about Alcon products.
Published as a promotional supplement to Ophthalmology Times®
9
References
1. Alio JL, Soria F, Abdou AA, Femtosecond laser assisted cataract
surgery followed by coaxial phacoemulsification or microincisional
cataract surgery: differences and advantages. Curr Opin Ophthalmol.
2014;25:81-88.
2. Mayer WJ, Klaproth OK, Hengerer FH, Kohnen T. Impact of crys­
talline lens opacification on effective phacoemulsification time in
femtosecond laser-assisted cataract surgery. Am J Ophthalmol.
2014;157(2):426-432.e1.
3. Hou JH, Prickett AL, Cortina MS, Jain S, de la Cruz J. Safety of fem­
tosecond laser-assisted cataract surgery performed by surgeons in
training. J Refract Surg. 2015;31(1):69-70.
PRACTICE PEARLS
Minimizing Surgeon/Patient
under the laser. Prior to the latest up-
and fragmentation. This reduction not
Anxiety: One of the most significant
grade, my average laser-on time was
only makes a difference in terms of
benefits to the introduction of the latest
between 45-55 seconds, and it’s now
overall flow efficiency, but it also reduces
LenSx Laser fragmentation pattern
been reduced to 15-30 seconds to
the stress level of patients and everyone
is the reduction in time patients require
complete all incisions, capsulotomy,
else in the laser room.
®
10 Cataract Refractive Surgery MYTH BUSTERS: Optimizing Procedures with the LenSx® Laser
LenSx® Laser Important Product Information
CAUTION: United States Federal Law restricts this device to
sale and use by or on the order of a physician or licensed
eye care practitioner.
INDICATION: The LenSx® Laser is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of
single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or
consecutively during the same procedure.
RESTRICTIONS:
• Patients must be able to lie mat and motionless
in a supine position.
• Patient must be able to understand and give an i
nformed consent.
• Patients must be able to tolerate local or topical
anesthesia.
• Patients with elevated IOP should use topical
steroids only under close medical supervision.
CONTRAINDICATIONS:
• Corneal disease that precludes applanation of the cornea
or transmission of laser light at 1030 nm wavelength
• Descemetocele with impending corneal rupture
• Presence of blood or other material in the anterior
chamber
• Poorly dilating pupil, such that the iris is not peripheral
to the intended diameter for the capsulotomy
• Conditions which would cause inadequate clear-ance
between the intended capsulotomy depth and the
endothelium (applicable to capsulotomy only)
• Previous corneal incisions that might provide a potential
space into which the gas produced by the procedure
can escape
• Corneal thickness requirements that are beyond the
range of the system
• Corneal opacity that would interfere with the laser beam
• Hypotony or the presence of a corneal implant
• Residual, recurrent, active ocular or eyelid disease,
including any corneal abnormality (for example, recurrent
corneal erosion, severe basement membrane disease)
• History of lens or zonular instability
• Any contraindication to cataract or keratoplasty
• This device is not intended for use in pediatric surgery.
WARNINGS: The LenSx® Laser System should only be operated by a physician trained in its use.
The LenSx® Laser delivery system employs one sterile disposable LenSx® Laser Patient Interface consisting of an
applanation lens and suction ring. The Patient Interface is
intended for single use only. The disposables used in conjunction with ALCON® instrument products constitute a
complete surgical system. Use of disposables other than
those manufactured by Alcon may affect system performance and create potential hazards.
The physician should base patient selection criteria on professional experience, published literature, and educational
courses. Adult patients should be scheduled to undergo cataract extraction.
PRECAUTIONS:
• Do not use cell phones or pagers of any kind in the
same room as the LenSx® Laser.
• Discard used Patient Interfaces as medical waste.
AEs/COMPLICATIONS:
• Capsulotomy, phacofragmentation, or cut or incision
decentration
• Incomplete or interrupted capsulotomy, fragmentation,
or corneal incision procedure
• Capsular tear
• Corneal abrasion or defect
• Pain
• Infection
• Bleeding
• Damage to intraocular structures
• Anterior chamber muid leakage, anterior chamber
collapse
• Elevated pressure to the eye
ATTENTION: Refer to the LenSx® Laser Operator’s Manual
for a complete listing of indications, warnings and precautions.
VERION™ Image Guided System – VERION™ Reference Unit and VERION™ Digital Marker – Important Product Information
CAUTION: Federal (USA) law restricts this device to sale by,
or on the order of, a physician.
INTENDED USES: The VERION™ Reference Unit is a preoperative measurement device that captures and utilizes a
high-resolution reference image of a patient’s eye. In addition, the VERION™ Reference Unit provides pre-operative
surgical planning functions to assist the surgeon with planning cataract surgical procedures. The VERION™ Reference
Unit also supports the export of the reference image, preoperative measurement data, and surgical plans for use with
the VERION™ Digital Marker and other compatible devices
through the use of a USB memory stick. The VERION™ Digital Marker links to compatible surgical microscopes to display concurrently the reference and microscope images,
allowing the surgeon to account for lateral and rotational
eye movements. In addition, details from the VERION™ Reference Unit surgical plan can be overlaid on a computer
screen or the physician’s microscope view.
CONTRAINDICATIONS: The following conditions may affect
the accuracy of surgical plans prepared with the VERION™
Reference Unit: a pseudophakic eye, eye fixation problems,
a non-intact cornea, or an irregular cornea. In addition, patients should refrain from wearing contact lenses during the
reference measurement as this may interfere with the accuracy of the measurements. The following conditions may
affect the proper functioning of the VERION™ Digital Marker: changes in a patient’s eye between pre-operative measurement and surgery, an irregular elliptic limbus (e.g., due
to eye fixation during surgery, and bleeding or bloated conjunctiva due to anesthesia). In addition, the use of eye drops
that constrict sclera vessels before or during surgery should
be avoided.
WARNINGS: Only properly trained personnel should operate
the VERION™ Reference Unit and VERION™ Digital Marker.
Use only the provided medical power supplies and data
communication cable. Power supplies for the VERION™
Reference Unit and the VERION™ Digital Marker must be
uninterruptible. Do not use these devices in combination
with an extension cord. Do not cover any of the component
devices while turned on. The VERION™ Reference Unit uses
infrared light. Unless necessary, medical personnel and patients should avoid direct eye exposure to the emitted or
reflected beam.
PRECAUTIONS: To ensure the accuracy of VERION™ Reference Unit measurements, device calibration and the reference measurement should be conducted in dimmed ambient light conditions. Only use the VERION™ Digital Marker in
conjunction with compatible surgical microscopes.
ATTENTION: Refer to the user manuals for the VERION™
Reference Unit and the VERION™ Digital Marker for a complete description of proper use and maintenance of these
devices, as well as a complete list of contraindications,
warnings and precautions.
CENTURION® Vision System Important Product Information
CAUTION: Federal (USA) law restricts this device to sale by,
or on the order of, a physician.
As part of a properly maintained surgical environment, it is
recommended that a backup IOL Injector be made available
in the event the AutoSert® IOL Injector Handpiece does not
perform as expected.
INDICATION: The CENTURION Vision system is indicated
for emulsification, separation, irrigation, and aspiration of
cataracts, residual cortical material and lens epithelial cells,
vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection.
The AutoSert® IOL Injector Handpiece is intended to deliver
qualified AcrySof® intraocular lenses into the eye following
cataract removal.
®
The AutoSert IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert® IOL Injector Handpiece is indicated for use with the AcrySof®
®
lenses SN6OWF, SN6AD1, SN6AT3 through SN6AT9, as well
as approved AcrySof® lenses that are specifically indicated
for use with this inserter, as indicated in the approved labeling of those lenses.
WARNNGS: Appropriate use of CENTURION® Vision System
parameters and accessories is important for successful procedures. Use of low vacuum limits, low flow rates, low bottle
heights, high power settings, extended power usage, power
usage during occlusion conditions (beeping tones), failure to
sufficiently aspirate viscoelastic prior to using power, excessively tight incisions, and combinations of the above actions
may result in significant temperature increases at incision
site and inside the eye, and lead to severe thermal eye tissue damage.
Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye. Ensure
that tubings are not occluded or pinched during any phase
of operation.
The consumables used in conjunction with ALCON® instrument products constitute a complete surgical system. Use of
consumables and handpieces other than those manufactured by Alcon may affect system performance and create
potential hazards.
AEs/COMPLICATIONS: Inadvertent actuation of Prime or
Tune while a handpiece is in the eye can create a hazardous
condition that may result in patient injury. During any ultrasonic procedure, metal particles may result from inadvertent
touching of the ultrasonic tip with a second instrument. Another potential source of metal particles resulting from any
ultrasonic handpiece may be the result of ultrasonic energy
causing micro abrasion of the ultrasonic tip.
ATTENTION: Refer to the Directions for Use and Operator’s
Manual for a complete listing of indications, warnings, cautions and notes.
Published as a promotional supplement to Ophthalmology Times® 11
LenSx® Laser Myth Busters. Copyright 2015.
Published as a promotional supplement to Ophthalmology Times.
© 2015 Novartis 8/15 LSX15043JS
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