Section a2, a4 and a5: unknown/ asked but not available.Section d6b: if explanted, give date: unknown, information not provided.Section h3: other 81: the device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 04/4/2024.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection of the complaint lens revealed that it was cut into three pieces and coated in viscoelastic residue.The lens was cleaned and damage on the surface of the lens and haptics were observed.No further issues were identified.Conclusion: the complaint issue "lens damaged" was not identified during product evaluation.The observed "cosmetic issues" is similar to the reported complaint issue.However, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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