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 b3 - date of event: unknown, as information was requested but not provided section d4 - catalog number: a complete number is unknown, as product lot number was not provided.Section d4 - expiration date: unknown, as product lot number was not provided.Section d4 - lot number: unknown/not provided section d4 - udi number: unknown, as product lot number was not provided.Section d6a - implant date: not applicable.Healon is not an implantable device.Section d6b - explant date: not applicable.Healon is not an implantable device.Section e1 - telephone number: (b)(6).Section h3 - other (81): the healon pro was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.Section h4.Device manufacture date: unknown, as the lot number of the device was not provided.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
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