MAUDE Adverse Event Report: LASIK SURGERY; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Visual Impairment (2138)

Event Date 10/06/2021

Event Type  Injury  

Event Description

I had lasik surgery 6 months ago and didn't get the proper results.After the initial surgery my eyes felt like they were on fire for hours.It was miserable.I had "starbursting" in my vision and issues with see well in low light.I had to get a prescription for glasses.My optometrist said i could try again in 6 months to get an "enhancement".I did this last week.I didn't have the pain afterwards but did have major pain during the surgery.I now have worse starbursting effect and still need glasses.I wish i never had the surgery.(b)(6).Fda safety report id # (b)(4).

• Brand Name: LASIK SURGERY
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 12634187
• MDR Text Key: 276836581
• Report Number: MW5104628
• 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: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 88