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LASIK ALL WAVEFRONT Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Retinal Tear (2050)
Event Date 04/15/2013
Event Type  Injury  
Event Description
I had lasik refractive surgery and 2.5 months later started experiencing bright flashing lights in my left eye.I went back to the doctor whom performed my lasik procedure and was told that my symptoms were not related to my laser surgery.He referred me to a retinal specialist whom i saw the same day.The retinal specialist examined my eye and found two tears in my retina.He then performed surgery that day.I was told that the retinal tears were common with people like me who were nearsighted.I'm only (b)(6) and my nearsightedness prior to lasik was not on the severe side.
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Brand Name
Type of Device
MDR Report Key3233918
MDR Text Key3665257
Report NumberMW5030924
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 07/14/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2013
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
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age26 YR
Patient Weight57