MAUDE Adverse Event Report: LASIK SURGERY

Event Date 10/01/2005

Event Type  Injury  

Event Description

Lasik surgery left me with double vision in one eye and the two eyes don't align, so i have triple vision. F/u surgery reduced this somewhat, so that the extra images are like ghost images, and i usually only notice 2 of them. Because i have large pupils and they did not increase the size of the flap to account for it, i get "edge" effects from the flap. This results in light diffraction. The effect is similar to looking through gauze. In bright conditions it can be quite pretty (my lawn sparkles like diamonds after the rain) but impairs my vision significantly (it's hard to see anything else while dazzled by a million diamonds) and impairs my ability to drive. Every point of light is a starburst coming from a bright "buckyball", and there's the ghost images of them to deal with also. The effects are often so bright that it is exquisitely painful. Polarized glasses help somewhat, but can't be worn at night or in other low light conditions. In dim lighting, the gauze effect can make it difficult to focus on things, a walk through the woods becomes a walk through shades of green that i can't determine the distance to. Date of event is approximate. (b)(6).

• Brand Name: LASIK SURGERY
• Type of Device: LASIK SURGERY
• MDR Report Key: 3354582
• Report Number: MW5031811
• Device Sequence Number: 1
• Product Code: LZS
• Report Source: Voluntary
• Reporter Occupation: PATIENT
• Type of Report: Initial
• Report Date: 09/11/2013

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 09/12/2013
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL

Patient TREATMENT DATA

Date Received: 09/12/2013 Patient Sequence Number: 1