MAUDE Adverse Event Report: WAVEFRONT LASIK; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Headache (1880); Visual Impairment (2138); Halo (2227); Decreased Sensitivity (2683)

Event Date 04/04/2019

Event Type  Injury  

Event Description

Underwent lasik surgery in (b)(6) of 2019.Have 20/20 visual acuity, however the glare, halos, and decreased contrast sensitivity have led to disabling life conditions, social isolation, and migraines.I would never recommend this surgery to anyone based on side effects that are irreversible.Though an elective surgery, these are debilitating side effects that will have a lifetime quality of life effect and the emotional and psychological effects of common side effects of this surgery are not discussed, instead the surgery is heavily marketed as being completely safe.Fda safety report id# (b)(4).

• Brand Name: WAVEFRONT LASIK
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 12697399
• MDR Text Key: 278610017
• Report Number: MW5104951
• Device Sequence Number: 1
• Product Code: LZS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/21/2021

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: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 41 YR