MAUDE Adverse Event Report: LASIK LASERS; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Visual Impairment (2138); Halo (2227); Anxiety (2328); Depression (2361)

Event Date 05/15/2020

Event Type  Injury  

Event Description

I had lasik eye surgery on (b)(6) 2020.When i went in for a consultation they gave me very little information about the side effects or complications possible.I went in ignorant trusting in the doctor who told me i would be able to see clear right away.I went in happy and hopeful.My prescription post op was -10, -9.At my preop appointment the surgeon told me i was going to need reading glasses but she didn't clarify that she meant the surgery would take my close up vision and i would need glasses right away.She asked me if the eye techs "yolf" me about monovision option and i said yes, but i didn't like that option.She then asked if they talked to me about halos, i said yes.The whole time she was giving off a weird vibe like she didn't really think i should have the surgery.She stared at the chart for a while and said under her breathe "i'll just make the flap thin." and she closed the folder.Well i lost my close up vision and need reading glasses.I'm 3 months post operation and still have dry eyes, halos, glare, starburst, and bad night vision.Due to this surgery i have fallen into anxiety and major depression.I have to take pills everyday to function.Lasik should not be fda approved.It does more damage than good.Fda safety report id# (b)(4).

• Brand Name: LASIK LASERS
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 10419960
• MDR Text Key: 203693588
• Report Number: MW5096112
• 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: 08/13/2020

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 64