Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.If implanted; give date: healon pro is not an implantable device.If explanted; give date: healon pro is not an implantable device; therefore, not explanted.(b)(6).Device evaluation: no sample was returned for investigation and therefore product evaluation cannot be performed.A product deficiency is not confirmed.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification. a search revealed that no additional complaints for this order number have been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
|