Section a3, a4 and a5: information requested however, not provided.Section b3 date of event: unknown/not provided section d4: serial #: unknown/not provided.Section d4: model # unknown/not provided.Section d4: catalog # unknown/not provided.Section d4: expiration date: unknown, as the serial number of the device was not provided.Section d4: udi #: a complete udi # is unknown as product serial number was not provided.Section h4.Device manufacture date: unknown, as the serial number of the device was not provided.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Correction: in follow up #1 it was reported that the issue of the infections had been resolved by the customer (internally) and that the cause was identified to be a new employee that was not following proper aseptic protocols.It was failed to mention that the j&j device is no longer a suspect product as it did not cause or contribute to the reported event based on the information that was received from the customer.Therefore, the reportability of this case was downgraded, and no additional information will be provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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