Weight and ethnicity: unknown, information not provided.If implanted, give date: not applicable as this is not an implantable device. if explanted, give date: not applicable as this is not an implantable device. all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
|
Section d9.Device available for evaluation? yes.Returned to manufacturer on: nov.11, 2021.Section h3.Device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification revealed trace amounts of viscoelastic residue on the inside of the cartridge.Further inspection revealed a crack on the cartridge.The lens was visually inspected under magnification as well, which revealed viscoelastic residue on the optic body and haptics.The lens was cleaned, and a torn iol and lens damage was observed.The complaint issue cartridge crack could be confirmed; however, this may be attributed to an inadequate amount of ovd, suggested by the trace amounts of viscoelastic residue on the inside of the cartridge, it cannot be confirmed to be related to a manufacturing issue.The complaint issue lens damage could be confirmed; however, this may be attributed to handling during the return process, suggested by the fact that the lens was crushed in the lens insert, and cannot be confirmed to be related to a manufacturing issue.The complaint issue stuck in cartridge could not be confirmed.Therefore, no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that five additional complaint was received from this production order.Even though, four of these complaints are related to this complaint, no product deficiency was identified in any of these.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.
|