MAUDE Adverse Event Report: EYE LASER; EXCIMER LASER SYSTEM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Dry Eye(s) (1814); Blurred Vision (2137); Eye Pain (4467)

Event Date 01/07/1993

Event Type  Injury  

Event Description

Dry eyes, eye pain, blurred 1; on (b)(6) 1993 dr (b)(6) did r-k.My prescription was not a good one for rk but he said it was perfect.I said i could wait for lasik but he said this is great now.Then he put cuts right to the center of my eye.He destroyed my vision forever.I complained and he sent me down to see dr.(b)(6).Dr.(b)(6) did 10 more surgeries like prk and lasik, all which made it worse but one.These doctors are all dirt bags that are in it for the money.This surgery needs to be stopped.Full of false advertising.Now i need to get scleral lenses, very expensive and a huge hassle.Fda safety report id # (b)(4).

• Brand Name: EYE LASER
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 12438865
• MDR Text Key: 270824193
• Report Number: MW5103769
• Device Sequence Number: 1
• Product Code: LZS
• 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: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Disability
• Patient Age: 61 YR
• Patient Weight: 95