Age, weight and ethnicity: unknown/ not provided.Implant date : not applicable as this is not an implantable device.Explant date : not applicable as this is not an implantable device.Initial reporter telephone number: (b)(6).It was indicated that the device is not returning 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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Section d9: device available for evaluation: yes date returned to manufacturer: 28 june 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The visual inspection of the returned complaint sample did not confirm the presence of material finds as reported by the customer nor was a product defect or deficiency found.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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