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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VISX VISX VISX STAR EXCIMER LASER

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VISX VISX VISX STAR EXCIMER LASER Back to Search Results
Model Number B
Event Date 10/23/1997
Event Type  Injury  
Event Description

In 1997, i had lasik surgery performed on both eyes. I had an enhancement in 2005, 1998 on my right eye. I now suffer from debilitating starbursts, halos, poor contrast and depth perception, and severely limited low light vision. Where i once was able to drive freely at night, i can no longer get around even on foot. Even in daylight i often mix up my own children with other people's children from distances as short as 6 feet away. I also suffer severe headaches from intense eye strain and the use of pilocarpine drops -. 5%-. Pre-existing conditions were: congenital nystagmus, myopia, astigmatism, night blindness - able to drive at night. My pre-operative readings were: measurement od os ou vcc 20/20020/40020/200 bscva 20/40 - 20/50, 20/10020/40 - 20/50. Refraction. -10. 00, -5. 75 x 010, 20/80, -10. 50, -6. 00 x 155. 20/200, 20/75. My current visual acuity is around 20/60 - 20/70 ou. Although i visited dr's office numerous times to seek help with the symptoms mentioned above, i was always told that everything was perfect and that these "side effects" were temporary and would go away, which they never did. In 2001, i finally gave up on dr and saw another lasik practitioner who informed me that i had decentered ablations, due to my nystagmus and that i was contraindicated for lasik at that time. I later learned that i also had significant higher order aberrations and was also contraindicated, due to the degree of my myopia and my pupil size. Dates of use: 1997 and 1998. Diagnosis of reason for use: improve vision to 20/40 ou, eliminate need for glasses or contact lenses. Event abated after use stopped or reduced: no.

 
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Brand NameVISX
Type of DeviceVISX STAR EXCIMER LASER
Manufacturer (Section D)
VISX
MDR Report Key1193647
Report NumberMW5008592
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/08/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/08/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberB
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 10/08/2008 Patient Sequence Number: 1
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