Catalog #: a complete catalog # is unknown as lot number was not provided.Unique identifier (udi#): a complete udi# is unknown, as lot number was not provided.Expiration date: unknown, as lot number was not provided.If implanted; give date: n/a (not applicable).The cartridge is not an implantable device.If explanted; give date: n/a (not applicable).The cartridge is not an implantable device; therefore, not explanted.Title, last name: unknown, information not provided.Device manufacture date: unknown as lot number was not provided.Device evaluation: the complaint sample was not returned to the manufacturing site (the cartridge was discarded); therefore, product testing could not be performed, and the customer's reported complaint could not be verified.Manufacturing record evaluation: manufacturing record review cannot be performed since the lot number is unknown.A search of complaints related to lot number cannot be performed since the lot number is unknown.Conclusion: since no sample was returned and the lot number is unknown an investigation could not be performed, and no malfunction is confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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It was reported by the customer that a zcb00 model intraocular lens (iol) was stuck in inserter and had plunger rod issue.Additional information was received stating that the lens was partially delivered into the patient's right eye, and was stuck in cartridge.No surgical interventions such as vitrectomy, incision enlargement or sutures were required.The replacement lens used is a zcb00 21.0 diopter lens.The patient was doing great at the time of discharge.The device was noted to be discarded.No further information was provided.
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