Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d4 - model #: the model # is unknown, as product lot number was not provided.Section d4 - catalogue#: the catalogue # is unknown, as product lot number was not provided.Section d4 - lot#: unknown/ not provided.Section d4 - expiration date: unknown as product lot number was not provided.Section d4 - udi #: unknown as product lot number was not provided.Section e1 - telephone number: (b)(6).Section h3 - other (81): the phaco tip was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.Device history record, complaint trending, and risk documentation for this device could be not be performed as the lot number was unknown.Section h4 - device manufacturing date: unknown / not provided.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.H3 other text : see h10.
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