Medical Device Daily Washington Editor

FDA evidently found a lot not to like in its September-October inspection of intraocular lens maker EyeKon Medical (Clearwater, Florida), and although it appears that no complaints have arisen in connection with the companies products, the agency handed EyeKon a Dec. 9 warning letter bearing nine citations for deviating from the quality systems regulations.

The warning letter, posted just last week to the agency web site, makes note of post-inspectional correspondence from the company dated Oct. 13, 2008, but FDA informed EyeKon that despite "your firm's efforts to come into compliance," the lack of supporting documentation included with the Oct. 13 letter left the agency without any certainty as to whether those corrections had fixed the problems.

The lead citation in the warning letter, and a commonplace citation on warning letters in general, deals with corrective and preventive action (CAPA). FDA states in the letter that the company did not follow procedures directing that "completion dates be entered on the CAPA" record and that the quality department review the company's electronic CAPA database at least every other week. However, some CAPAs dating back as far as 2006 lacked dates or evidence of biweekly monitoring.

Another citation notes that an August 2008 test for residual aluminum on intraocular lenses performed by an outside lab identified out-of-specification (OOS) residual aluminum. The firm sent another 10 pairs of lenses were sent for further testing, and FDA cited EyeKon for not being able to document whether the 10 additional pairs were from the same lot of lenses that came up OOS.

FDA also cited EyeKon for problems with requalification of a sterilizer and with less than exhaustive implementation of "a procedure for monitoring the microbial/pyrogenic quality of water" for polishing and hydrating acrylic lenses.

In an e-mailed statement, Sam Fizer, the company's VP for quality and engineering, stated that "EyeKon has received a positive letter from the FDA and all the issues appear to have been resolved."

In another warning letter action, FDA slapped Amedica (Salt Lake City) with a Jan. 27 warning letter citing the maker of vertebral spacers for claims that were not among those in its 510(k) filing for the Valeo compact vertebral spacer.

The letter states that a product specification sheet seen by the agency's investigator indicates that the device "is designed with uoro, a hollow core to accept autograft or biologics" despite that the 510(k) authorizes the device's use "only with bone graft." The warning letter also states that the Valeo was described in a video as used in cervical spine applications despite having been cleared only for use in thoracic and lumbar portions of the spine.

Amedica's CEO, Ashok Khandkar, PhD, told Medical Device Daily, "we believe our response should have resolved their concerns," but said they have not heard back from FDA.

ThermoGenesis, FDA agree to recall remedy

ThermoGenesis (Rancho Cordova, California), a supplier of products and services that process and store adult stem cells, said that FDA has agreed with its plan to remedy the voluntary recall of certain lots of AXP disposable bagsets that it reported in November.

At that time, the company had indicated that the recall was not the result of any safety issues; the field action was a result of the potential for particulates to be released into the sterile, non-pyrogenic fluid path as a result of a defective component provided by one of the suppliers to the company. The company also indicated that it was providing customers a blood filter to be used, as necessary, with any bags that had already been processed.

"We are pleased with the decision by the FDA regarding our remediation effort to address this issue," said Matthew Plavan, CEO. "As we indicated at the time we announced the recall, we believed that the $520,000 we had reserved to cover any costs related to this recall would be sufficient, and in fact, we may be able to recoup some of that reserve going forward," he added.

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