Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.If implanted, give date: unknown, information not provided.If explanted, give date: not applicable, as the lens remains implanted.Telephone number: (b)(6).The device was not returned for evaluation as the lens remains implanted in the eye.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 h3 - device evaluated by manufacturer? yes.Device evaluation: product evaluation was performed by our subject matter expert (sme) on customer's provided photographs.The photographs displayed the anterior segment of a pseudophakic eye.A mark/crack can be observed paracentral on the optical portion of the lens.The potential root cause and clinical impact on the patient cannot be determined from a photo assessment.The complaint issue of cosmetic 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 as, per manufacturing protocol, the complaint lens is optically inspected for defects prior to being placed in the lens case.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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