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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHOTOREFRACTIVE KERATECTOMY PRK

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PHOTOREFRACTIVE KERATECTOMY PRK Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Red Eye(s) (2038); Blurred Vision (2137); Excessive Tear Production (2235); Disability (2371)
Event Date 02/10/2011
Event Type  Injury  
Event Description

I had prk performed last year. Fortunately, i did not have the pain that some have described post procedure, however, i had blurred vision for at least 6 months. Luckily i only had my left eye treated. There is no way i could have driven or performed my job had i had both eyes treated. Today, over a year post procedure, i have developed pain, redness, blurred vision, and extremely watery eye. This procedure is barbaric, had i been better informed by the practitioner performing the procedure, or done more research about post-procedure complications, i doubt i would have undergone the procedure.

 
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Brand NamePHOTOREFRACTIVE KERATECTOMY
Type of DevicePRK
MDR Report Key2541249
MDR Text Key2602025
Report NumberMW5025070
Device Sequence Number1
Product Code HNO
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 04/14/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/14/2012
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? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 04/14/2012 Patient Sequence Number: 1
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