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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK SURGERY
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LASIK SURGERY Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Visual Impairment (2138)
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).

 
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Brand NameLASIK SURGERY
Type of DeviceLASIK SURGERY
MDR Report Key3354582
MDR Text Key3809303
Report NumberMW5031811
Device Sequence Number1
Product Code LZS
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
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 Received09/12/2013
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
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