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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUMMIT TECHNOLOGY, INC. EXCIMER LASER

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SUMMIT TECHNOLOGY, INC. EXCIMER LASER Back to Search Results
Event Date 07/04/2010
Event Type  Injury  
Event Description

Laser-assisted in-situ keratomileusis -lasik- surgery was performed on both eyes in 1996, when first approved by the fda. Since then, i have suffered multiple side effects such as dry eyes, star bursts, diminished night vision resulting in inability to drive at night, loss of lasik correction, among others. About 10 years ago, both eyes suffered tears and holes in the retina, requiring laser surgery. Since 04/2009, i've undergone two cataract surgeries on my right eye; an initial surgery and repeat surgery to replace the iol. On (b)(6) 2010, i suffered a complete retinal detachment resulting in blindness in the right eye. After emergency surgery in the hospital under general anesthesia, the vision is slowly recovering. Dates of use: (b)(6) 1996. Diagnosis or reason for use: myopia.

 
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Brand NameEXCIMER LASER
Type of DeviceEXCIMER LASER
Manufacturer (Section D)
SUMMIT TECHNOLOGY, INC.
MDR Report Key1824683
Report NumberMW5017296
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Type of Report Initial
Report Date 07/20/2010
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received08/23/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No

Patient TREATMENT DATA
Date Received: 08/23/2010 Patient Sequence Number: 1
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