MAUDE Adverse Event Report: ALCON LABORATORIES, INC. LASIK MACHINE; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Visual Impairment (2138); Discomfort (2330)

Event Date 01/14/2016

Event Type  Injury  

Event Description

I had lasik performed; i was told lasik was right for me and i was a good candidate.Turns out i have very large pupils and was lied to.I have horrible night vision now and even after being fit with specialty contacts (which is still ongoing) by a specialist, i am still have some distorted vision at night.My eyes are also not as comfortable as they were pre lasik.Please have lasik pulled off the market.Fda safety report id # (b)(4).

• Brand Name: LASIK MACHINE
• Type of Device: EXCIMER LASER SYSTEM
• Manufacturer (Section D): ALCON LABORATORIES, INC.
• MDR Report Key: 11412619
• MDR Text Key: 235038598
• Report Number: MW5099777
• 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: 03/01/2021

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: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 77