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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK NONE

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LASIK NONE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Vitreous Floaters (1866); Retinal Tear (2050); Visual Impairment (2138); Visual Disturbances (2140)
Event Date 04/11/2012
Event Type  Injury  
Event Description
I had lasik surgery on (b)(6) 2012. Vision improved to 20/20. I went for my six week post surgery check-up on (b)(6) 2012 and notified the clinic that i had seen floaters for the first time on the friday before. On that wednesday morning, i experienced white flashes as well as many floaters. I was then refered to a retinal specialist that afternoon. The retinal dr found a tear or hole in the retina and performed surgery that same day to repair the damage. I am 5 days post surgery, still good vision. I was very myopic, -7 and was told that the retinas are thinner on people like me and are more prone to tears and that my episode was not related to the lasik surgery.
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Brand NameLASIK
Type of DeviceNONE
MDR Report Key2544688
MDR Text Key2607288
Report NumberMW5025114
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 04/16/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2012
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/16/2012 Patient Sequence Number: 1