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
• 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

• 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