Section a2, a4, a5 patient information: not applicable, not asked because the product did not touch the eye.Section d6a, if implanted, give date: not applicable.The lens did not contact the eye.Section d6b, if explanted, give date: not applicable.The lens did not contact the eye.Therefore, not explanted.Section h3-other (81): the device was not returned for evaluation as it was discarded.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.
|