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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CUSTOM INTRALASE LASIK

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CUSTOM INTRALASE LASIK Back to Search Results
Event Date 07/13/2009
Event Type  Injury  
Event Description

After custom intra-lase lasik on both eyes to correct myopia, i suffer from double vision -diplopia- due to exotropia. Before surgery, because i was slightly overcorrected with my contact lenses, i did not suffer from double vision or exotropia. The doctors who screened me for lasik failed to check for this or notice the problem, and now, i suffer from severe daily pain, eye strain, and double vision. Prism lense and vision therapy have thus far not been able to treat the problem successfully. I also suffer from ghosting which impairs reading and computer work, and night vision problems, including large halos, starbursts, etc. These were not present a few months after surgery, but have gradually become worse starting at about six months after the lasik and continuing to the present. Finally, i suffer from dry eye. Collectively, this has been painful, debilitating, frustrating, and traumatic. My faith in the country, in humanity, in doctors has suffered a blow. Many doctors just want to protect lasik, they don't want to help me. I have quit one job due to the condition and i am struggling to finish a phd program. I may not be able to continue in the profession i have been trying for half of my life to enter -scholar of literature-. I suffer from anxiety, depression, and my life isn't the same. Please help regulate this industry which needs it so badly. (b)(4).

 
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Brand NameCUSTOM INTRALASE
Type of DeviceLASIK
MDR Report Key1887552
Report NumberMW5017961
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/23/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/23/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 10/23/2010 Patient Sequence Number: 1
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