Expiration date: unknown, as the lot number was not provided.Lot number: unknown, information not provided.Udi number: a complete udi# is unknown, as the lot number was not provided.Device manufacture date: unknown, as the lot number was not provided.If implanted, give date: not applicable, as the product is not implantable.If explanted, give date: not applicable, as the product is not implantable.Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing record review could not be performed because the lot number of the complaint product is unknown.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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It was reported that a za9003 21.5 diopter lens became stuck in an emerald cartridge while implanting the lens into the patient's operative eye.Reportedly, the lens was partially delivered with the optic/haptic having contact with the operative eye.Therefore, the lens was not used and another za9003 21.5 diopter lens was chosen as the replacement lens.Overall, there was no patient injury.No additional information was provided.This report encompasses the emeraldc30 cartridge associated with the 1st implant attempt out of 3.
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