Expiration date: unknown as product lot number was not provided.Lot number: unknown, as information was not available.Udi number: 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.Last name: unknown, not provided.Device manufacture date: unknown, as the lot number was not provided.Device evaluation: residues of viscoelastic was observed only at the cartridge tip and part of the tube of the 1mtec30.The cartridge is cracked, the hole (as described by the customer) is located at the cartridge tip and tube and the tip is deformed.The cartridge crack could be associated to the handpiece pushrod as reported by the customer.The reported issue was verified.Since the lens insertion preparation and delivery attempt could not be recreated, a product quality deficiency could not be confirmed.Manufacturing record review: a manufacturing record evaluation is not possible since the product identifiers are unknown.Since the product identifiers are unknown a search of complaints related to the production order is not possible.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
|