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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK LASIK EYE SURGERY

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LASIK LASIK EYE SURGERY Back to Search Results
Event Date 08/01/2003
Event Type  Injury  
Event Description

Lasik surgery done to correct a nearsighted vision problem in 2003, with a touch up done in 2004. Within a couple of years diagnosed with cataracts in both eyes. Just completed cataract removal in one eye with mixed results. Still need removal of cataract in right eye. Suspect original lasik surgery performed at (b)(6) as cause and effect of cataracts at such a young age. Better warnings and public awareness are needed to fully inform pts. Cataracts were never listed as an increased possibility at the initial surgery by (b)(6). I suspect i will need yet another eye surgery to again correct my vision, as less than desired results have happened with the removal of the left cataract.

 
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Brand NameLASIK
Type of DeviceLASIK EYE SURGERY
MDR Report Key2751763
Report NumberMW5026953
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 09/14/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/14/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 09/14/2012 Patient Sequence Number: 1
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