MAUDE Adverse Event Report: LASIK SURGERY; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Pain (1994); Loss of Vision (2139); Viral Infection (2248); Increased Sensitivity (4538); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/25/2019

Event Type  Injury  

Event Description

After being told that i was the perfect candidate for lasik, and was informed of only minimal side effects, i decided to have lasik surgery in both eyes.Immediately after the surgery i experienced excruciating light sensitivity.Within a week i started to have severe pain in my right eye.Within a couple of weeks i was blind in both eyes, being able to see only lights, shadows and colors.Lights were still excruciating painful, as well as stabbing pain in both eyes.The flap in my right eye became detached 3 times, resulting in 3 stitches being placed on my eye to hold it in place.This surgery was performed by the same surgeon who did my lasik surgery.I was finally referred to a corneal specialist who had to use an amniotic membrane to save my left eye.My right eye had experienced a viral infection which covered my entire eye, causing the blindness.The corneal specialist informed me that the reason for my complications was due to preexisting medical conditions, all of which i informed my lasik surgeon i had, and all of which he ignored, both during my initial consultation and after my surgery when i experienced a multitude of issues.The end result of all of this is permanent double vision, permanent severe dry eyes, reoccurring viral infections in my right eye, permanent night vision issues, and i never had the vision acuity that i was promised.Lasik is not a safe procedure! i was not provided a true informed consent of the real dangers and potential problems with the procedure, although my surgeon did comply with all current requirements for informed consent.Consumers need to be properly informed about the possible complications of lasik, no matter how rare, and a thorough evaluation of all medical conditions should be taken into account before informing the consumer about how fit they are for lasik.Or even better, take lasik off the approved fda list, saving thousands of eyes, and lives, every year.

• Brand Name: LASIK SURGERY
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 12108681
• MDR Text Key: 260244974
• Report Number: MW5102284
• 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: 06/30/2021

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?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR