MAUDE Adverse Event Report: LASIK; EXCIMER LASER SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 06/15/2007

Event Type  Injury  

Event Description

I had lasik eye surgery performed in 2000 by (b)(6).After a few years my vision deteriorated.After further consult with dr.(b)(6) he told me i was probably not a good candidate for the surgery.I searched for other eye doctors and eventually found (b)(6).He diagnosed my condition as ectasia due to the lasik.Initially there was no treatment for the condition.Eventually i was able to enter a clinical trial for a cornea collagen crosslinking treatment.The treatment was successful in keeping my condition from worsening, but did not improve the ectasia from which i still suffer today.Fda safety report id # (b)(4).

• Brand Name: LASIK
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 12532772
• MDR Text Key: 273648173
• Report Number: MW5104218
• 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: 09/22/2021

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 55 YR
• Patient Weight: 102