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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LADAR VISION 4000 EXCIMER LASER

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ALCON LADAR VISION 4000 EXCIMER LASER Back to Search Results
Event Date 09/07/2007
Event Type  Injury  
Event Description

I rec'd bilateral lasik with the alcon ladarvision 4000 sys. The treatment was wavefront guided utilizing the custom cornea software. A bd microkeratome with 180 micron head was used for flap creation. The optical zone used was 6. 5mm with a 9mm total ablation zone. Preoperatively, i was od: -5. 5d and os: -5d with. 75d astigmatism. My scotopic pupils were measured at 8. 3mm. Ever since surgery, i have suffered from large starbursting and halo under low light conditions and reduced low light contrast sensitivity. The bottom line is that i was not a candidate for refractive surgery in the first place: i was lied to and sold the procedure by my dr and his staff. The optical zone must be large enough to cover the scotopic pupil for surgery to be allowed, end of story. Why dose the fda continue to allow such dangerous and deceptive practices by refractive surgeons? it should be a contraindication for surgery if the scotopic pupil is larger than the proposed optical zone for the device. These visual disturbances are quite disturbing and dangerous for activities such as night time driving. They are very bothersome for any activity conducted in low light. Finding things in low light is much more difficult post surgery due to the reduced contrast sensitivity. The most blatant violation was treating me with an insufficient oz size, but other damages have resulted as well. I have corneal irregularities within the oz: central islands, as revealed by corneal topography scans. The alcon sys have been known to cause these complications; as such, they are dangerous devices and should be taken off market until these problems can be proven through testing, to be resolved. Another damage i have rec'd is high increase in floaters. These are caused by posterior vitreous detachment. Microkeratome suction rings are dangerous devices that create high intraocular pressures and stresses, causing damage to ocular structures like the vitreous humor and retina. As such, they should not be allowed. There are much safer, reliable surface ablation procedures for refractive surgery that do not involve microkeratomes and flap creation. The lasik flap never heals and remains as a life long interface. This leaves the cornea permanently weakened and vulnerable to trauma and flap dislocation. How does this permanent damage benefit the pt with previously healthy corneas? i was 19 at the time of surgery. The fda approval order for the ladar vision 4000 sys clearly state that this device is only indicated for use in those 21 yrs of age and older. I was not informed of this. In fact, my informed consent was highly insufficient. I was not provided a copy of the pt information handbook for the device, which is required to be given to prospective pts - as specified by the fda approval order and the operator device manual-. The pt info handbook contains studies and clearly outlines complications and their percentage of occurrence and also warns about scotopic pupils larger than the 6. 5mm oz. My informed consent contained no info about the risk for surgery due to my large pupils or the risk for vitreous detachment and floaters. The clear differences in safety between lasik, lasek, prk, etc. Were not presented so that i could make an informed choice on the type of procedure to choose. The summary of this complaint is as follows: the optical zone must be at least as large as the scotopic pupil. Surgery conducted outside of this is dangerous and visually damaging to the pt. A clear standard of care needs to be established for pupil size. Alcon devices have been shown to be inferior devices with comparatively high complication rates, particularly relating to central islands. The should be banned, investigated, and corrected before use is allowed in the future. Lasik is a dangerous procedure due to microkeratome flap creation. Surface procedures need to be advocated as safer alternatives. Strict guidelines regarding device use and reporting of complication need to be set and enforced. Success rates need to be based on what the pt deemed a success, not the dr. The pt is the one who has to live with their vision. Informed consent needs to be far more detailed and standardized for refractive surgery. Dates of use: 2007. Dianosis: correction of myopia.

 
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Brand NameLADAR VISION 4000
Type of DeviceEXCIMER LASER
Manufacturer (Section D)
ALCON
MDR Report Key1055498
Report NumberMW5007102
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 05/30/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/30/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 05/30/2008 Patient Sequence Number: 1
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