MAUDE Adverse Event Report: CUSTOM VU WAVEFRONT LASIK

Event Date 07/09/2007

Event Type  No Answer Provided  

Event Description

I had lasik surgery on (b)(6) 2007. The surgery was performed within 4 hrs of my initial visit. I have not had clear vision since the day of surgery. My problems include dry eyes, halos, starbursts, no contrast ability, lack of peripheal vision, extreme sensitivity to light, and now bilateral cataracts. I was told at every visit that these complications would resolve over time. Of anything, my symptoms have become worse. I faced an unk amount of surgeries to remove the cataracts and i am concerned about the instability of my corneas, which have been damaged and will at some point require corneal transplantation. At the time of my surgery, i was earning in excess of (b)(6) per yr. Due to my declining visual ability and debilitating depression, i am on (b)(6), wherein i receive a monthly stipend of (b)(6). I have attempted suicide more than 5 times since my lasik.

• Brand Name: CUSTOM VU WAVEFRONT
• Type of Device: LASIK
• MDR Report Key: 2019933
• Report Number: MW5019782
• Device Sequence Number: 1
• Product Code: LZS
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2011

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 03/10/2011
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Service Personnel
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Patient TREATMENT DATA

Date Received: 03/10/2011 Patient Sequence Number: 1