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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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LASIK Back to Search Results
Event Date 02/14/2008
Event Type  Injury  
Event Description

Lasik: i first had lasik in 2000; had a second procedure that fall. Most recently had lasik in which the cornea was manual scraped because it was noted that i had map-dot-dystropy. These procedures have been done in an attempt to eliminate halos and starbursts, and increase vision acuity. As of this date, no improvement. I also have had dry eye since the original procedure. Tried drops and tear-duct plugs; neither worked. Both upper and lower ducts have been cauterized. Perhaps some improvement, but still very dry eyes.

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Type of DeviceLASIK
MDR Report Key1167205
Report NumberMW5008337
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/18/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/2008
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

Date Received: 09/18/2008 Patient Sequence Number: 1