MAUDE Adverse Event Report: LASIK

Event Date 06/01/2011

Event Type  Injury   Patient Outcome  Hospitalization

Event Description

I had lasik surgery in 2001. I had extremely poor vision and was near sighted prior to the surgery. This year [2011] i lost nearly all of my sight due to a detached retina and macular pucker. I got my sight back after surgery. I have spoken to several people and they have told me that they know of several cases where someone has had the same problem and even lost their sight completely in one eye some time after having lasik surgery. I have asked my ophthalmologist and others involved in treating my condition and they all said emphatically that there is no connection between the two. I found on the web that it can be one of the outcomes in a small amount of cases. First, since it does not seem to be tracked and is not even acknowledged by many professionals it may be more prevalent than known and either way we should at least be warned of this possible complication. This was lasik surgery that i believed caused my detached retina.

• Brand Name: LASIK
• Type of Device: LASIK
• Device Event Key: 2383277
• MDR Report Key: 2359432
• Event Key: 2256288
• Report Number: MW5023294
• Device Sequence Number: 1
• Product Code: LZS
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/30/2011

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 11/30/2011
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Service Personnel
• Was Device Available For Evaluation?: No
• 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?

Patient TREATMENT DATA

Date Received: 11/30/2011 Patient Sequence Number: 1

#	Treatment	Treatment Date
NA