MAUDE Adverse Event Report: EXCIMER LASER; EXCIMER LASER SYSTEM

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Defective Device (2588)

Patient Problems Dry Eye(s) (1814); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Anxiety (2328); Depression (2361); Impaired Healing (2378); Eye Pain (4467)

Event Date 03/12/2021

Event Type  Injury  

Event Description

I had bladeless lasik on (b)(6) 2021.During the initial consultation, i was never informed of the four fda requirements by the doctor.Specifically the one that states the doctor is supposed to warn the patient of potential risks, complications, and alternatives.That was never once brought up during our consultation.It was never brought up the day of surgery.On my second follow-up, i brought up the fact that i am having trouble seeing at night.I am experiencing starbursts, glares, halos, and have difficulty driving at night.It comes and goes, but that was never discussed with me.I am an electrician by trade and the sole supporter of my family.I work swing shift and it is imperative that i am able to see at night to do my job as well as drive to different job sites.I never would have agreed to this procedure had i have known that.I also would not have agreed to it if i knew that the corneal flap never completely heals.I was not even made aware that a corneal flap was going to be cut.That was never once discussed during my consultation.I never would have followed through with this procedure had i have known that.We have three very young boys at home who are very active.I live in constant fear that they will hit me in the eye and dislodge my flat.My eyes are also intermittently dry and i occasionally get sharp pains in the corners of my eyes.When i tried to discuss my concerns with the doctor, the doctor stated that i signed a consent form and pulled it out of my file to show me my signature.This was never brought up during my consultation or discussed with me prior to the surgery.We also were rushed into signing because we had to switch offices to have the procedure done.The office in which we were originally scheduled had a system malfunction and their joystick broke on the laser.They called and scheduled me for a different location to "squeeze me in".It was very rushed.Because we were ill-informed, the mental anguish has been brutal on me and my family.We have suffered anxiety and depression in addition to physical complications.This is a sickening, predatorial practice that needs to be abolished.I firmly believe this is a direct violation of a physician's hippocratic oath of "do no harm", simply for the fact that they create irreversible and unpredictable harm in varying levels to every patient they operate on.Virtually every healthy eye is affected in a negative manner because of the trauma of the procedure.Company: wavefront.Fda safety report id#: (b)(4).

• Brand Name: EXCIMER LASER
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 11655620
• MDR Text Key: 245437212
• Report Number: MW5100737
• 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: 04/08/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 28 YR
• Patient Weight: 95