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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
Device Problem Insufficient Information (3190)
Patient Problems Vitreous Floaters (1866); Vitreous Detachment (2445)
Event Date 11/11/2016
Event Type  Other  
Event 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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MDR Report Key6114013
MDR Text Key60868939
Report NumberMW5066186
Device Sequence Number1
Product Code LZS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/16/2016 Patient Sequence Number: 1