MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. LASIK VISX STARS4 EXCIMER LASER; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Visual Impairment (2138); Loss of Vision (2139); Visual Disturbances (2140); Halo (2227); Anxiety (2328); Depression (2361); Suicidal Ideation (4429)

Event Date 02/11/2021

Event Type  Injury  

Event Description

I had lasik eye surgery (b)(6) 2021 by dr.(b)(6) with (b)(6).After lasik it's understood there is a healing process.After months of poor vision i decided to reach out to (b)(6).They quickly were able to identify the problem.Dr.(b)(6) told me that i had an "island" of distortion in the center of my cornea.He explained that the laser creates "smoke" as the laser burns your eye and as the laser comes back down the "smoke" from your burning cornea prevented the laser from correcting the target area of the cornea.This lead to a raised center portion "island" in my cornea resulting in higher order aberrations and irregular cornea shape.The complications and side effects i've experienced since lasik include: mild to severe dry eye, under corrected left eye, residual astigmatism, inability to focus, decreased vision at long distance, higher order aberration (right eye), irregular cornea shape (right eye), terrible low light and night vision, glare, halos, starbursts, diplopia- double vision, loss of quality near vision, loss of visual acuity, degraded vision, distorted vision, depression, anxiety, suicidal thoughts i am currently working with (b)(6) doctors to try and find a solution to my degraded and distorted vision from lasik.I would not call these complications or side effects.This is injury.Period.Hard/ridged contacts or scleral lenses is what we are going to attempt to try to enhance my vision.Dr.(b)(6) did two things very wrong in my opinion.He and his staff failed to fully explain to me the risks involved with lasik.His records indicate there was "face to face" time in counseling about risks prior to the procedure.This is a flat lie.They mailed me a consent form and that's the only warning of caution i received.I had fully been educated on the risks involved i would have never done the procedure.He and his staff have been very vague and deceptive about the results of my lasik surgery.In showing the topography pictures to other doctors it's easy to see the "island" of distortion in my right eye causing most of my vision problems which cannot be corrected with another surgery.Lasik has caused me to become very fearful and panic about my eyesight.Depression, anxiety, emotional trauma, and suicidal thoughts have followed lasik.Laser surgery needs to stop.Topographies show "island" of distortion and abnormal cornea shape resulting in higher order aberrations.Fda safety report id# (b)(4).

• Brand Name: LASIK VISX STARS4 EXCIMER LASER
• Type of Device: EXCIMER LASER SYSTEM
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.
• MDR Report Key: 12547418
• MDR Text Key: 273810287
• Report Number: MW5104272
• 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: 09/27/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ARTIFICIAL TEARS; OMEGA 3 FISH OIL FOR DRY EYES
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 36 YR
• Patient Weight: 98