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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKALCON LADARVISIONLASIK

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UNK ALCON LADARVISION LASIK   Back to Search Results
Event Date 07/14/2000
Event Type  Injury   Patient Outcome  Disability,Required Intervention
Event Description

I had lasik surgery on both eyes, to correct nearsightedness. Since the surgery, i experience visual distortions, such as halos, starbursting, glare, difficulty seeing clearly in most lighting-situations, except outdoors during the daytime (natural sunlight). There is also some dry eye, which was present, to a lesser degree, before the surgery. After the surgery, other optometrists (not the doctors involved in the surgery) told me that i should never have been considered as a candidate for lasik, due to my large pupils and existing dry eyes. My tbu is somewhere around 3-4; prior to the surgery, i was having trouble wearing contact lenses because of this dryness; i was told that lasik could help, as i would not need cls after the surgery. Ironically, the only thing that restores part of my night vision is rigid gas permeable lenses, which have to be fit by an expert. They are extremely difficult to tolerate and expensive. It is also extremely difficult to find a doctor with the experience for fitting contact lenses for these types of problems. It is also possible that equipment -malfunction may have occurred, as well. I have decentered ablations. In any case, my large 8mm pupils/dry eyes practically guaranteed that i would have the above mentioned aberrations. Any possible contraindications were downplayed. Pre-op, i had a definite intolerance to rgps -and even soft lenses. Lasik induces tear-film problems that exacerbate contact-lens intolerance. After years of struggling with soft contact lenses, i would never have risked being rendered dependent on a type of lens that i myself knew -and was known by doctors- that i was unable to wear. I believe that the initial fda study suffered from "under-reporting". That is, most people do not even know of this form. I, myself, only happened upon it by mere chance. I guarantee that there are far more than the "140" people suffering from life-changing lasik-induced problems. Again, i'm not sure what is being looked for. "therapy" would be theratears eyedrops to treat dry eye, and endless fittings for speciality contact lens -macrolenses, etc. This has been ongoing since 2000.

 
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Brand NameALCON LADARVISION
Type of DeviceLASIK
Manufacturer (Section F)
UNK
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unk
Manufacturer (Section D)
UNK
unk
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Device Event Key1006910
MDR Report Key1037838
Event Key996204
Report NumberMW5006615
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/01/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?

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