Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Date of event: unknown, exact date not provided.Best estimate was reported as the week of (b)(6) 2019.If implanted, if explanted, give date: unknown, information not provided.All pertinent information available to johnson and johnson surgical vision has been submitted.
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Device available for evaluation: yes, returned to manufacturer on: 9/9/2019.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The complaint product was not received in its original packaging, and packaging had a note which stated noted fiber on lens before inserting in eye.The plunger was in a partially advanced position.The cartridge was correctly engaged to the device.No assembly error and/or defect related to manufacturing process were observed.Visual inspection at microscope magnification was performed.Scarce amount of lubricant material residue was observed in the device.The lens was stuck at the cartridge tip.The complaint sample was evaluated under microscope on deferent bases (black and white).No foreign matter was identified on the sample returned.The lens was too hard, and it was not possible to remove it from the device.The reported issue of debris/particles could not be verified.Based in the analysis of the sample returned product quality deficiency could not be determined.Manufacturing record review: he manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.The search revealed no additional investigation requests received for this production order number.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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