MAUDE Adverse Event Report: LASIK EYE (LASER) MACHINE; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Emotional Changes (1831); Headache (1880); Pain (1994); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Depression (2361); Ambulation Difficulties (2544); Suicidal Ideation (4429)

Event Date 03/08/2018

Event Type  Injury  

Event Description

I had lasik eye surgery at (b)(6) and my vision is now worse than before having the procedure.I was in glasses almost immediately after surgery.I was suicidal and now deal with depression and ptsd from the procedure.They were dishonest about what they were going to do and deny it now.They performed monovision without telling me that's what it was and fully disclosing information.I would not have approved if they had been truthful.I have blurred vision, daily migraines, trouble walking and with depth perception, sensitivity to light, inability to focus, cannot drive at night, have starbursts, halos, hoas and severe dry eye and eye pain.(b)(6).Fda safety report id # (b)(4).

• Brand Name: LASIK EYE (LASER) MACHINE
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 11998616
• MDR Text Key: 256176412
• Report Number: MW5101867
• 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: 06/10/2021

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: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DRY EYE DROPS; HOT AND COLD COMPRESSES; IBUPROFIN; REWETTING DROPS; SINUS RINSES; VIAMIN C AND D
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 44 YR
• Patient Weight: 88