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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN LASIK

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UNKNOWN LASIK Back to Search Results
Lot Number UNKNOWN
Event Date 11/01/2000
Event Type  Injury  
Event Description

I am a physician in (b)(6). I was evaluated and felt to be a good candidate for lasik surgery in both eyes, with adequate corneal thickness. Within 2 years, i started noticing significant deterioration of my vision. I have been part of contact lens clinical studies, multiple refractions, and currently wear piggyback contacts in each eye in order to cope during the day. I am unable to drive at night and unable to wear glasses that will help to any degree. I have had to cut back my hours practicing as a physician as the reading and driving required are often prohibitive to me. I am now being evaluated for corneal transplant in both eyes. As a physician, i am appalled that this surgery was offered with this complication as a known outcome even for good candidates and am consistently appalled that it is advertised the way it is. I believe lasik should be withdrawn.

 
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Brand NameLASIK
Type of DeviceLASIK
Manufacturer (Section D)
UNKNOWN
MDR Report Key2321288
Report NumberMW5022901
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/30/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/30/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Service Personnel
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No

Patient TREATMENT DATA
Date Received: 10/30/2011 Patient Sequence Number: 1
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