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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK SURGERY
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LASIK SURGERY Back to Search Results
Medical Device Problem Code Insufficient Information (3190)
Health Effect - Clinical Codes Vitreous Floaters (1866); Vitreous Detachment (2445)
Date of Event 11/11/2016
Type of Reportable Event Other
Event or Problem Description
On (b)(6) 2016, i experienced a cloud over my right eye vision, appearance of significant volume and size of floaters, and rapid flashing lights.I went to the fr of a local eye hospital immediately the next morning on the advice of my eye doctor.I was diagnosed with posterior vitreous detachment (pvd) in the right eye.I had lasik surgery in 2005 and experienced occasional floaters over the past 10 years.I have been researching the link between lasik surgery and retinal/vitreous issues that may be related to weakening of these eye structure as a side effect of lasik.I am only (b)(6) and in excellent health.Pvd is a health issue related to aging and common in older adults >65 years.
 
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Brand Name
LASIK SURGERY
Common Device Name
LASIK SURGERY
MDR Report Key6114013
Report NumberMW5066186
Device Sequence Number14817432
Product Code LZS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 11/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Operator of Device No Information
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/16/2016
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ACETAMINOPHEN; IBUPROFEN
Outcome Attributed to Adverse Event Other;
Patient Age49 YR
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