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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN RADIAL KERATOTOMY

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UNKNOWN RADIAL KERATOTOMY Back to Search Results
Event Date 08/05/2010
Event Type  Injury  
Event Description

Radial keratotomy complications 14 years after surgery. Halos, ghosting, shadows, blurring, starburst, diminished contrast, depth, and night vision, dizziness, photophobia, rapid degeneration of eyesight. Rapid decline of vision 14 years after radial keratotomy. Dates of use: (b)(6)1994. Diagnosis or reason for use: astigmatism, nearsightedness.

 
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Brand NameRADIAL KERATOTOMY
Type of DeviceRADIAL KERATOTOMY
Manufacturer (Section D)
UNKNOWN
MDR Report Key1798702
Report NumberMW5017030
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/06/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 08/06/2010 Patient Sequence Number: 1
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