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 temporal 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 temporaily where keratome entered the eye. " a bandage contact lens was placed and pt was given vigamox. Patient was transported 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 report of an adverse event from facility. Rep reported that while using the mk-2000, the patients anterior chamber of the right cornea was perforated, on the temporal 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.

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Be wary of eye centers that advertise, "20/20 vision or your money back" or "package deals." There are never any guarantees in medicine.

In my view, an even more repugnant approach is the "money back guarantee". This implies that the procedure is somehow reversible and that there are no potential risks of sight-threatening or sight-disturbing complications. Getting one's money back does not make up for a lifetime of unhappiness about one's vision; it is not like returning a broken television.