Age, weight, ethnicity: information unknown/ not provided.Per regulation eu (b)(4)(general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.If explanted, give date: not applicable, as the lens remains implanted.Telephone number: (b)(6).The device was not returned for evaluation as the lens remains implanted in the eye.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.
|