Subsequent to, and as a direct result, of this surgery the pt acquired chronic impaired night vision - starburst, glare, and halos.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037644

Pt had lasik surgery at facility by dr. In 1999, on his left eye. Subsequent to, and as a direct result, of this surgery the pt acquired chronic impaired night vision - starburst, glare, and halos. Additionally, he has dramatically reduced contrast sensitivity. This was confirmed on a contrast sensitivity test in 2000, where his left eye scored 50% but his right eye - unoperated - 100%. Because of the devastating negative outcome the patient decided against the planned lasik surgery on the right eye. The disparity in the visual acuity of his eyes resulted in a secondary condition of anisometropia and he is now dependent upon a contact lens in his unaltered right eye as his only means of balanced, corrected vision. As to a cause of the negative outcome it became clear to the patient after second and third medical opinions that his left pupil size was large and made him a poor candidate for lasik - 6mm ablation zone and patient has 8mm to 9mm pupils on low light. Facility incorrectly assessed his pupil size at 6mm in low light. The patient recalls that his screening by a technician at facility was done only using a card with varying sizes of black circles. He now has learned this to be the most primitive of techniques in assessing pupil size and there is also no standard for pupil measurement - whether devices or techniques - in the u. S. He is also dismayed that dr. Did not independently verify his pupil size at any point prior to surgery. There is apparently no surgical recourse for this outcome of poor night vision, anisometropia and loss of contrast sensitivity, none of which were disclosed in his consent form for the off label use of the summit laser for lasik. In 1999. Lasik surgery performed by dr. At facility, affiliated with another facility-. Dates of use: one day in 1999. Diagnosis or reason for use: correct lasik refractive eye surgery.