Eight (8) devices were received for evaluation.A visual inspection was performed and loose particulate matter (pm) was identified on the outside wall of the inner pouch of five (5) units and on the inside wall of the inner pouch of two (2) units.No pm was found in one (1) unit.The pm was analyzed microscopically and the pm was determined to be a fiber in five units, room-temperature-vulcanizing (rtv) silicone in one unit, and an unidentified particle in one unit.The size of the pm was determined to be under 0.80 mm squared and met specification.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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