MAUDE Adverse Event Report: LASIK; EXCIMER LASER SYSTEM

Device Problem Use of Device Problem (1670)

Patient Problems Cataract (1766); Dry Eye(s) (1814); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/15/1999

Event Type  Injury  

Event Description

I had lasik done on both eyes, i didn't get notification about any side effects.Both eyes are severely dry, i had cataracts at an early age, wrinkled retinas which needed additional surgery to avoid becoming permanently blind.Also have other miscellaneous eye issues.

• Brand Name: LASIK
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 16818863
• MDR Text Key: 314113932
• Report Number: MW5117075
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): 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: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White