MAUDE Adverse Event Report: VISX S-4 EXCIMER LASER EX LASER WITH A BLADE

Device Problem Insufficient Information (3190)

Patient Problems Dry Eye(s) (1814); Pain (1994); Visual Impairment (2138); Burning Sensation (2146)

Event Date 09/17/2009

Event Type  Injury  

Event Description

Prk surgery. Never told of any possible dry eye complications. Have severe dry eyes. I do not believe i was ever tested for dry eyes. Not fully informed about the complications and risk. Was in waiting room to have lasik when an employee of office sitting beside of me was having prk and talked me into having prk instead of lasik. Nothing ever said to me about the possibility of dry eyes. Have plugs now and eyes still hurt and burn everyday. Prescription was around -4 and still way off from 20/20. Still need glasses, eyes hurt all the time, but i'm (b)(6) more poor. This is the biggest scam ever. Doctors are making a killing and never telling pts the real side effects. My doctor was dr (b)(6).

• Brand Name: VISX S-4 EXCIMER LASER
• Type of Device: EX LASER WITH A BLADE
• MDR Report Key: 1970111
• MDR Text Key: 1734420
• Report Number: MW5019097
• 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: 01/19/2011

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 01/19/2011
• 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

Patient TREATMENT DATA

Date Received: 01/19/2011 Patient Sequence Number: 1