MAUDE Adverse Event Report: WAVELIGHT GMBH (PRESSATH) ALLEGRETTO WAVE; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Emotional Changes (1831); Eye Injury (1845); Pain (1994); Visual Impairment (2138)

Event Date 02/03/2021

Event Type  Injury  

Event Description

Permanently impaired vision; i had lasik and was promised it was a safe and harmless procedure.I now use (b)(6) of eye drop a month to survive, need all instant medical attention, have a constantly changing prescription, corneal chronic pain and dryers.It was destroyed my quality of life and my mental well-being.Lasik is hands down the worst thing that has ever happened to me.And i was a perfect candidate and went to a top doctor.My eyes had no problems before.I didn't even need eye drops.No my day centers around eye drops.I've met hundreds in my same situation.Something needs to be done.Exonerated laser wave tech allegretto.Fda safety report id# (b)(4).

• Brand Name: ALLEGRETTO WAVE
• Type of Device: EXCIMER LASER SYSTEM
• Manufacturer (Section D): WAVELIGHT GMBH (PRESSATH)
• MDR Report Key: 12467101
• MDR Text Key: 271530474
• Report Number: MW5103892
• 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: 09/10/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 37 YR
• Patient Weight: 59