MAUDE Adverse Event Report: LASIK SURGERY; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Pain (1994); Visual Impairment (2138); Visual Disturbances (2140)

Event Date 08/01/2020

Event Type  Injury  

Event Description

I received complications from lasik surgery.The complications weren't explained before surgery.The complications i received were extreme dry eyes, extreme eye pain, and extreme starbursts and glares from lights.The lasik doctors and their staff neglected to explain the complications from the surgery and performed the surgery anyways.This procedure should be banned from occurring in the united states.Fda safety report id# (b)(4).

• Brand Name: LASIK SURGERY
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 10658553
• MDR Text Key: 211061078
• Report Number: MW5097178
• 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: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Weight: 91