MAUDE Adverse Event Report: LASIK; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Eye Injury (1845); Vitreous Floaters (1866); Discomfort (2330); Eye Pain (4467)

Event Date 06/01/2019

Event Type  Injury  

Event Description

Had lasik surgery around 2001.Was only told that i would need reading glasses around age 50.Was not told i would have dry eyes, floaters, and puckering of my retina due to having laser surgery.These conditions are quality of life altering.Hard to work, constant eye irritation, daily discomfort.Fda safety report id # (b)(4).

• Brand Name: LASIK
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 13500423
• MDR Text Key: 285431252
• Report Number: MW5107340
• 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: 02/06/2022

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: 02/08/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White