MAUDE Adverse Event Report: MEDITEC LASER EXCIMER, MEDITEC

Device Problem Insufficient Information (3190)

Patient Problems Flashers (1864); Headache (1880); Blurred Vision (2137); Halo (2227); Complaint, Ill-Defined (2331); Depression (2361)

Event Date 05/02/1995

Event Type  Injury  

Event Description

I was operated for myopia and astigmatism in 1995 (i had 15 diopters). Since then, i suffer irreversible sequela: halos, glare, flashes, depression with the intent of suicide, reduction on the sensibility to contrast, blurred nocturnal vision and artifical light. I cannot drive at night, i have problems reading or working with the computer, headache, ocular hypertension, cataracts. All this prevented me to have a normal life and work. I would like to know if you know of any solution. Manufactured as oscar blanco lara.

• Brand Name: LASER EXCIMER, MEDITEC
• Type of Device: LASER EXCIMER, MEDITEC
• Manufacturer (Section D): MEDITEC
• MDR Report Key: 5053545
• MDR Text Key: 25039669
• Report Number: MW5055893
• 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: 08/07/2015

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/07/2015
• Is This An Adverse Event Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Was Device Available For Evaluation?: No Answer Provided
• Is The Reporter A Health Professional?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient TREATMENT DATA

Date Received: 08/07/2015 Patient Sequence Number: 1