Additional narrative: section b3- unknown/ information not provided.Section d4- model number: unknown, information not provided.Section d4- serial number: unknown, information not provided.Section d4- udi number: a complete udi number is unknown, as the serial number was not provided.Section d6a-unknown, information not provided.Section d6b-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.An attempt has been made to obtain missing information; 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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