MAUDE Adverse Event Report: CUSTOM VU WAVEFRONT LASIK

Device Problem Insufficient Information (3190)

Patient Problems Cataract (1766); Dry Eye(s) (1814); Increased Sensitivity (2065); Visual Impairment (2138); Loss of Vision (2139); Visual Disturbances (2140); Halo (2227); Depression (2361); Disability (2371)

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
• MDR Text Key: 1916047
• Report Number: MW5019782
• 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

• 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: OTHER
• 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