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Keratome Catastrophy
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Author:  Broken Eyes [ Tue Apr 04, 2006 1:40 am ]
Post subject:  Keratome Catastrophy

http://www.accessdata.fda.gov/scripts/c ... _ID=596836

"In 2005, the physician was creating a temporal incision on a hyperopic (right) eye with handpiece, 160 um blade holder/9. 5 ring combination. The blade holder assembly engaged in the anterior chamber, it went deep into the cornea, the iris prolapsed and the eye lost pressure, creating lost of vacuum to the ring. At that moment, the physician was not able to retract the blade holder; therefore she used an instrument like forcepts to assist with the removal of the blade holder from the cornea. After removal of blade holder, dr noted the incision length to be 4 mm; the physican used a viscoelastic agent to reform the anterior cornea and placed approx eight (10-0 nylon) single sutures on the cornea. The pt's eye was in stable condition. In 04/2005, the handpiece, blade holders and rings were received at nidex, inc. Two days later, the pt was reported to be stable with poor vision, able to count fingers, sutures remaining inplace with no signs of infection and using antibiotic drops. The physician continues close follow-up with pt. Currently, co is unable to determine root cause of this incident."

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