Adverse Event Re****ted to FDA MedWatch
Manufacturer Narrative
The following is a description of the event as relayed to nidek inc
both verbally and on the mk complaint form by loden vision center: in
2008, the physician was creating a tem****al incision on the pt's
mayopic right eye, with the mk-2000 hand piece, 180um blade holder and
the 9. 0mm suction ring combination. The microkeratome was placed on
the cornea, good suction obtained and noted. Keratome "bucked" and
stopped. Physician stated "keratome appeared to have jammed into the
lid speculum. " the microkeratome was removed from the pt's eye and
reinspected, proper assembly confirmed, wedge in place and full test
run performed. "all appeared normal. " suction ring was placed back on
the cornea and suction acquired. Microkeratome advanced and
immediately stopped when suction was lost. Microkeratome was removed
from the pt's eye. "anterior chamber noted to be flat, but
anatomically intact. " "anterior chamber filled with viscoat as large
opening tem****aily where keratome entered the eye. " a bandage contact
lens was placed and pt was given vigamox. Patient was trans****ted to
the operating room and the cornea was sutured. The following month,
dr's handpiece and blade holder were received at nidek inc. For
inspection. Prior to the inspection, it was found that this
microkeratome had not been serviced for 3 years. During the
inspection, the technician found the hand piece ot be out of
specification and the blade holder had damage on the surface. It is
nidek's conclusion that the problems found with the microkeratome did
not attribute to the incident of the perforated cornea. It has been
determined as user error.
Event Description
On 03/31/08, nidek inc rec'd re****t of an adverse event from facility.
Rep re****ted that while using the mk-2000, the patients anterior
chamber of the right cornea was perforated, on the tem****al side of
the eye. Rep stated, that the perforation was not near the visual axis
and that the pt's vision was not affected. The pt required 3 sutures
on the cornea. Dr loden stated that during the procedure the mk-2000
(keratome) may have come in contact with the lid speculum while
creating the corneal flap causing the keratome to "dive" into the
eye.
Source:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1032770
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