MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. / ABBOTT MEDICAL OPTICS (AMO) VISX STAR S4; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Depression (2361); Suicidal Ideation (4429)

Event Date 01/27/2022

Event Type  Injury  

Event Description

Received idesign lasik surgery with dr.(b)(6) on (b)(6) 2022.I was told i was a perfect candidate.Since surgery i've had debilitating visual aberrations that have reduced my quality of life to a minimum existence.My career as a photographer was discussed as being compatible with the surgeon before lasik, and i now have lost clients and feel i need to change jobs as my vision isn't able to perform the clear, detailed work demanded of me - things are distorted in all lighting, and my vision is especially blurry on a computer screen.I'm racked with regret and guilt, and deeply depressed with passing suicidal thoughts.I've had an outside corneal specialist take scans, and am informed that i had corneal irregularity, along with a pupil size that is too big for the proper treatment zone.I understand this is an elective procedure, but to withhold information about probability and reality of risks is deceptive, when transparency should be held to a high standard in medicine.Fda safety report id # (b)(4).

• Brand Name: VISX STAR S4
• Type of Device: EXCIMER LASER SYSTEM
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC. / ABBOTT MEDICAL OPTICS (AMO)
• MDR Report Key: 14161453
• MDR Text Key: 289664708
• Report Number: MW5109171
• 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: 04/19/2022

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: 04/20/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White