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 d6a - implant date: not applicable, the cartridge is not an implantable device.Section d6b - explant date: not applicable, the cartridge is not an implantable device.Section e1 - telephone number: (b)(6).Section h3 - other (81): the cartridge 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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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It was reported that three (3) lenses were found to be scratched after implantation.The surgeon suspects, that the cartridges are the problem, because the scratches were not visible until the lens was in the eyes of the patients.The lens remains implanted and no further details were provided.This is report 3 out of 3.
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