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: 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 Number: 1
• Patient Outcome(s): Disability
• Patient Age: 26 YR
• Patient Weight: 57