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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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Device Problem Insufficient Information (3190)
Patient Problems Retinal Detachment (2047); Visual Impairment (2138)
Event Date 06/01/2011
Event Type  Injury  
Event Description
I had lasik surgery in 2001. I had extremely poor vision and was near sighted prior to the surgery. This year [2011] i lost nearly all of my sight due to a detached retina and macular pucker. I got my sight back after surgery. I have spoken to several people and they have told me that they know of several cases where someone has had the same problem and even lost their sight completely in one eye some time after having lasik surgery. I have asked my ophthalmologist and others involved in treating my condition and they all said emphatically that there is no connection between the two. I found on the web that it can be one of the outcomes in a small amount of cases. First, since it does not seem to be tracked and is not even acknowledged by many professionals it may be more prevalent than known and either way we should at least be warned of this possible complication. This was lasik surgery that i believed caused my detached retina.
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Brand NameLASIK
Type of DeviceLASIK
MDR Report Key2359432
MDR Text Key2376549
Report NumberMW5023294
Device Sequence Number1
Product Code LZS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/30/2011
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2011
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No

Patient Treatment Data
Date Received: 11/30/2011 Patient Sequence Number: 1