Not applicable, as there was no patient contact with the product.If implanted, give date: not applicable, as there was no patient contact with the product.If explanted, give date: not applicable, as there was no patient contact with the product.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.Attempts were made to contact the customer requesting additional information regarding the complaint; however, to date, no response has been received.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: yes.Section d9: returned to manufacturer on: jul 13, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The complaint folding carton was received with the tamper sticker broken.The complaint lens was received inside of the original lens case and inside of sealed sterilization pouches.The complaint issue "sterility assurance concerns" was not confirmed.The complaint issue of "packaging issues" was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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