Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted; give date: n/a.The healon is not an implantable device.If explanted; give date: n/a.The healon is not an implantable device; therefore, not explanted.(b)(6).The healon is not returning for evaluation as it was discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, 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 and johnson surgical vision, inc.Has been submitted.
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