MAUDE Adverse Event Report: LASIK/PRKEYE CORRECTION SURGERY DEVICES

Event Date 02/10/2006

Event Type  Injury  

Event Description

Lasik, prk eye surgery left eye prk, right eye lasik. Extreme difference from l to r eye. Left eye also still has bad astigmatism, had to get prescription reading glasses for one eye to slow down headaches. I paid the extra per eye, for lifetime touch up. After waiting 1 yr, i went back to see if they could balance out the eye better and was told no. Unless they get worse than 20/40 they would not do it. That was not told to me at the time of surgery. Why pay the extra money then? i am now very light sensitive. As my md told me, photo-phobic. The need for sunglasses is all the time and i have even had a few episodes that were so severe that i had to pull over when driving. It is interfering with my work. Floaters or what i would term as dirt floating around in the eyes, which is really loose blood vessels. I was told that these would go away after a few weeks as they started shortly after the surgery. It's been a year and a half and there's still a lot of them.

• Brand Name: LASIK/PRK
• Type of Device: EYE CORRECTION SURGERY DEVICES
• Device Event Key: 1007614
• MDR Report Key: 1038117
• Event Key: 996473
• Report Number: MW5006698
• Device Sequence Number: 1
• Product Code: LZS
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/04/2008

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 05/04/2008
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: Service Personnel
• Is The Reporter A Health Professional?: No
• Was The Report Sent To Manufacturer?: No
• Is the Device an Implant?: No

Is this an Explanted Device?