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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RADIAL KERATOTONY -RK- NONE

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RADIAL KERATOTONY -RK- NONE Back to Search Results
Event Date 06/01/1995
Event Type  Injury  
Event Description

At (b)(6), in 1995, i chose refractive eye surgery called rk. It was a (b)(6) copay per eye at the time and although a bit radical, even scary, the testimonials and advertising of the day were convincing. The benefit was amazing, for 12 to 13 yrs, then things began going south. An attempt to return to glasses for correcting the mono-vision that i had were impossible to use. So they were put away and i just continued to cope with deteriorating vision. Nothing dramatic, just fuzzy. I had no idea that my rk decision had enrolled me in a club that i didn't want to be a part of. Folks that were led down the primrosed path of corrective eye surgery without studies that plainly indicated the future complications. Three weeks ago i woke to find i could not read the time 8 feet away. Fortunately that was a morning thing and hasn't repeated too often. However, i've learned that my eyes are now left 20/60 and right 20/150 for distance and the right eye, my reading eye, is 20/30 for reading. I'm (b)(6) retired and just finished out my vision (b)(6) insurance on the last of oct. [paste in a frown]. The important part is that i'm discovering and reading much about the entire post rk population and problems online. I can see that i've paid my dues and i am a full fledged member with an unk future.

 
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Brand NameRADIAL KERATOTONY -RK-
Type of DeviceNONE
MDR Report Key1899807
Report NumberMW5018177
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/10/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/10/2010
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: 11/10/2010 Patient Sequence Number: 1
Treatment
RK REFRACTIVE EYE SURGERY
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