MAUDE Adverse Event Report: LASER (LASIK); EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Visual Impairment (2138); Halo (2227); Increased Sensitivity (4538)

Event Date 01/12/2019

Event Type  Injury  

Event Description

I had lasik surgery in 2019.I must still wear glasses since my vision is now 20/50 not much better than before, but what's worse is the halos, starburst, and glare including rainbow glare that still prevent me from being able to drive a car at night.This has left me dependent on others for transportation and/or means i have to pay drivers to get around at night.I also had to change my work schedule as a result.I was told the bad effects would go away over time but more than 4 years later i still cannot drive at night.I also have problems with dry eye plus light sensitivity during daylight hours.

• Brand Name: LASER (LASIK)
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 16953924
• MDR Text Key: 315561516
• Report Number: MW5117654
• 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: 05/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• 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): Other
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White