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.Device evaluation: visual inspection using magnification was performed.Viscoelastic residue was observed at the cartridge tip.The cartridge tip was observed deformed and damaged, confirming the reported issue.The condition of the returned cartridge is consistent with a unit that has been damaged possibly by the contact of the metal rod tip from the hand piece tool during surgical process.There is no evidence to suggest that the complaint sample has been affected by the manufacturing process.No product deficiency was identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints revealed two other complaints were received under this production order; however, were not confirmed as a manufacturing error.Labeling review: the labeling review was completed and revealed that the directions for use (dfu) adequately provide instructions, precautions, along with warnings 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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