[251019]
On december 22, 2000, moria's distributor, moria, inc. (formerly microtech, inc. ), issued a "product alert" (the "alert") to each of its customers on record as having purchased microkeratome blades from specified production lots for use with the moria carriazo-barraquer (cb) microkeratome. The alert was issued in follow up to communications between moria, inc. And a small number of its customers who reported an increased incidence of imperfectly cut corneal flaps in lasik procedures involving the cb microkeratome. A representative sample alert is attached to this narrative. The alert was issued as a precautionary measure after moria attempted to determine whether there was any connection between cb blades that had been recently distributed and contemporaneous reports of cutting imperfections. However, because blades are typically disposed of once used, moria was able to recover only a small number of blades that were said to actually have been used in lasik procedures involving reports of imperfectly cut flaps. And even among these, some returned blades were retrieved from disposal bins, where they would have been unprotected and likely damaged. While moria was unable to confirm that there was any problem with the blades when they were initially shipped, the company, out of an abundance of caution, halted the shipment of blades from product lots in the relevant time period, contacted all customers who had purchased blades from these lots, and offered to exchange the blades for replacements. Upon moria's inspection of these returned blades, the company found that a limited number had slight cutting edge irregularities, although the cause of these irregularities could not be established. The primary purpose of the alert was to reiterate the blade inspection process that surgeons performing lasik should already have been following. Toward this end, the alert reminded surgeons of the procedures for inspecting cb blades prior to use in lasik. Finally, as a demonstration of moria's commitment to its products and its customers, the alert stated that moria had implemented new testing standards and new testing equipment that exceeded industry standards. Blades produced under the new inspection process, the alert stated, would be available within weeks. The co did not file a report at the time the alert was issued because there was no indication that a problem existed with moria's manufacturing process or that a cutting edge irregularity would be likely to cause or contribute to a death or serious injury, as those terms are defined in the fda's medical device reporting regulations, particularly if surgeons or technicians properly inspected blades before using them. Nor was there any indication that any of the blades in question had actually caused or contributed to a death or serious injury. In fact, as noted, while a small number of customers did report an increased incidence of imperfectly cut flaps none of them reported any serious injury to any lasik patient. The co has no reason today to change their assessment. There has been no recurrence of the irregularities reported in late 2000. However, moria, inc. Has been named in a small number of lawsuits claiming injuries based on allegedly defective blades. Moria, inc. Is currently in the process of defending these suits, and has been attempting to obtain additional information, such as might be contained in patient medical records, to assess the validity of the allegations made. Thus far, neither moria nor moria, inc. Has found any evidence that an irregular cb blade caused or contributed to any of the injuries alleged in these suits, or that an irregular cb blade manufactured by moria would be likely to cause or contribute to any serious injury in other cases. Nonetheless, out of an abundance of caution, and in light of the allegations in the lawsuits the co has elected to file this report to inform the fda of these events.
Patient Sequence No: 1, Text Type: D, B5