MAUDE Adverse Event Report: LASIK; POWERED LASER SURGICAL INSTRUMENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Increased Sensitivity (2065); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)

Event Date 05/07/2018

Event Type  Injury  

Event Description

Multi focal iol lenses placed in both eyes, yag procedure shortly batter and then, two separate lasik enhancements to "fix" the problem but just made things worse and they wanted to do a 3rd i had problems from the very beginning nightmare! among other things, my iris in my left eye was damaged from the initial surgery to never return to normal absolutely debilitating vision lost the perfect distance vision that i had glare, halos, ghosting, extreme light sensitivity and i could go on and on nobody deserve this nobody.They are butchering peoples eyes for life destroyed the career i have loved for 24 yrs, i found out i was never a candidate for these lenses i had them removed and replaced plus a pupil cerclage.My eyes are damaged forever.This is not ok i've been an er rn for 23 yrs and i can't believe i let someone do this to me and i can't believe that the fda continues to let this go on.I would be glad to talk to anyone willing to listen.Too much to discuss in email.Bottom line please make this stop people do not deserve this.I was shocked to find out how many people are affected/lives ruined by elective eye surgeries especially lasik it's truly gut wrenching this is a regret i will always have to live with.It should be stopped immediately from: (b)(6).Fda safety report id # (b)(4).

• Brand Name: LASIK
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• MDR Report Key: 11372673
• MDR Text Key: 233739385
• Report Number: MW5099605
• Device Sequence Number: 2
• 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: 02/21/2021
• 2 Devices were Involved in the Event: 1 2

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: 02/23/2021
• 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: 51 YR