Lot#: unknown/not provided.Expiration date: unknown, as product lot number was not provided.Udi #: a complete udi # is unknown as product 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.(b)(6).Device manufacture date: unknown, as the lot number of the device was not provided. device evaluation: the product testing could not be performed as the product was not returned.The reported complaint could not be verified.Manufacturing record review: the manufacturing record review and historical complaint 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 for the proper use and handling of the product.Conclusion: 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.
|