MAUDE Adverse Event Report: LIGHT LASER TECHNOLOGIE AG WAVELIGHT ALLEGRETTO WAVEZ EXCIMER LASER SYSTEM

Device Problem Insufficient Information (3190)

Patient Problems Cataract (1766); Dry Eye(s) (1814); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Depression (2361)

Event Date 02/01/2006

Event Type  Injury  

Event Description

I had lasik surgery in (b)(6) 2006 and i have been struggling with complications since. Before my surgery i was assured i had < 1% chance of having gash or any other long term complications. I noted this on my consent form. Prior to the surgery i told the surgeon i have a very low tolerance for a bad outcome and gash. He repeatedly told me "pupil size is not a good predictor of poor post lasik night vision. " he assured me that as a "compatriot" he would take good care of me and that i "would do fine. " immediately following surgery, i developed dry eye which is worsening. I developed all the gash symptoms even though i was told i had < 1% chance of having any long term complications. The possibility of dry eye was never discussed with me. The only complications we discussed were gash because i initiated. After complaining about dry eye my surgeon told me i had dry eye before surgery. I thought this was a contraindication for lasik. Other contraindications for lasik: pre-existing dry eye, occupation -computer programmer-, large pupils, high correction, astigmatism, medications, long term contact lens use and possibly cataracts. I have been seeing the surgeon the entire time for follow ups, gash, dryness and cataracts with no resolution in sight. This has severely impacted my life to the point where my 3 yr relationship with my fiance ended. I am finding it very difficult to concentrate/work and i have become depressed as nothing helps and the drs are stumped.

• Brand Name: WAVELIGHT ALLEGRETTO WAVEZ EXCIMER LASER SYSTEM
• Type of Device: WAVELIGHT ALLEGRETTO WAVEZ EXCIMER LASER SYSTEM
• Manufacturer (Section D): LIGHT LASER TECHNOLOGIE AG; wolfsmantel 5; erlangen 9105 8; GM 91058
• MDR Report Key: 2021735
• MDR Text Key: 19662367
• Report Number: MW5019804
• 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: PATIENT
• Type of Report: Initial
• Report Date: 03/11/2011

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 03/11/2011
• 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 TREATMENT DATA

Date Received: 03/11/2011 Patient Sequence Number: 1

Treatment

AZASITE; LEXAPRO 20 MG/DAY; KLONOPIN 1 MG/DAY; REMERON 30 MG/DAY; EYE DROP OF ALL SORTS; HYDROCORTISONE CREAM; CELEXA 40 MG/DAY; KLONOPIN .5 MG/DAY; DOXYCYCLENE; ALPHAGAN; LID HYGIENE/SCRUBS; REMERON 15 MG/DAY; PILOCARPINE; LOTEMAX