MAUDE Adverse Event Report: LASIK MACHINE

Device Problem Insufficient Information (3190)

Patient Problems Cataract, Induced (1767); Therapeutic Response, Decreased (2271)

Event Date 01/01/2008

Event Type  Injury  

Event Description

I had lasik surgery in both eyes in 2008, had to have an enhancement in my left in 2013. My annual check up was this week and my eye doctor noted i now have cataracts developing in both eyes that were not there in 2009, 2013 before my enhancement or any of my checkups. I have development in the 6 yrs since my initial lasik. I am (b)(6) with no previous history of cataracts or medical reason for them to develop. (b)(6).

• Brand Name: LASIK MACHINE
• Type of Device: LASIK
• MDR Report Key: 4825141
• Report Number: MW5042971
• Device Sequence Number: 1
• Product Code: LZS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Patient Age: 25 YR
• Patient Weight: 58
• Patient Treatment(s): OTC MEDS: TYLENOL PM MELATONIN ALLEGRA; RX MEDS: TOPAMAX 100MG ATENOLOL 50MG
• Patient Outcome(s): Disability