MAUDE Adverse Event Report: LASIK EYE SURGERY

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 03/30/2006

Event Type  Injury  

Event Description

I had lasik eye surgery in (b)(6) 2006 by an extremely reputable doctor.A few months later, vision in right eye rapidly deteriorated.It wasn't until 2 years after the procedure that i was diagnosed with post lasik ectasia.It was another year before the symptoms appeared in my left eye.Since then i have spent much time, energy and money attempting to save what vision i have left and avoid having cornea transplants.

• Brand Name: LASIK EYE SURGERY
• Type of Device: LASIK
• MDR Report Key: 3966350
• MDR Text Key: 4635919
• Report Number: MW5037468
• 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: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 29 YR
• Patient Weight: 82