Additional information: sections a-2 patient age and date of birth, a-4 patient weight, and a-5 patient ethnicity and race: unknown/asked information unavailable.Section d-6a date implanted: unknown/asked information unavailable.Section d-6b date explanted: unknown/asked information unavailable.Section h3-81: 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.Section h-6 medical device problem code: 3191 unspecified/other w/patient involvement used to capture complications during surgery.Attempts were made to contact the customer account requesting additional information regarding 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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