MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS LASIK WAVEFRONT

Device Problem Insufficient Information (3190)

Patient Problems Dry Eye(s) (1814); Visual Impairment (2138)

Event Type  Injury  

Event Description

I got lasik a few years ago and now have worsened dry eyes, and my night vision is significantly impaired. I don't experience severe halos, but enough to make a difference. The worst however is lowered perception of shades of gray/darkness, which makes it more difficult to see clearly in low light conditions.

• Brand Name: LASIK WAVEFRONT
• Type of Device: LASIK WAVEFRONT
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS
• MDR Report Key: 3542249
• MDR Text Key: 4126303
• Report Number: MW5033610
• Device Sequence Number: 1
• Product Code: LZS

Combination Product (Y/N)

• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: PATIENT
• Type of Report: Initial
• Report Date: 12/23/2013

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/24/2013
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL