MAUDE Adverse Event Report: LASIK ALL WAVEFRONT

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.

• Brand Name: LASIK ALL WAVEFRONT
• Type of Device: LASIK
• MDR Report Key: 3233918
• MDR Text Key: 3665257
• Report Number: MW5030924
• Device Sequence Number: 1
• Product Code: LZS

Combination Product (Y/N)

• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 07/14/2013
• 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 TREATMENT DATA

Date Received: 07/14/2013 Patient Sequence Number: 1