If implanted; give date: n/a (not applicable).The cartridge is not implantable device.If explanted; give date: n/a (not applicable).The cartridge is not implantable device; therefore, not explanted.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Device available for evaluation? yes, returned to manufacturer on 3/13/2018.Device returned to manufacturer? yes.Device evaluation: the two (2) emeraldc30 cartridges were received in a plastic bag.Visual inspection using microscope magnification was performed.Sample #1: the cartridge was observed with the tip deformed.Evidence of viscoelastic residues, ovd (ophthalmic viscosurgical device), was observed in the cartridge tube, tip, wings, and loading zone.Based on the evidence observed, this cartridge has been handled and prepared for surgical use.Sample #2: the cartridge was observed with the tip deformed.Evidence of viscoelastic residues, ovd (ophthalmic viscosurgical device), was observed in the cartridge tube, tip, wings, and loading zone.Based on the evidence observed, this cartridge has been handled and prepared for surgical use.The deformed tip condition observed on both returned samples #1), and #2) is consistent with units that have been damaged by accident while inserting the cartridges into the metal slot of the handpiece during the surgical process.The reported issue was verified on the two samples returned.There is no evidence to suggest that the complaint samples have been affected by the manufacturing process.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions, precautions, and 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.Due to johnson and johnson surgical vision receiving timeout issues the esg gateway on the evening of april 21, 2018.This report is being submitted the following the day as the issues seem to be resolved.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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