Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Lot number : unknown.Udi : unknown.Catalog: unknown.If implanted; give date: n/a.The viscoelastic is not an implantable device.If explanted; give date: n/a.The viscoelastic is not an implantable device; therefore, not explanted.(b)(6).(b)(4).Device evaluation: since no sample was returned for investigation product evaluation is not performed and a product deficiency is not confirmed.Manufacturing records review: manufacturing record review cannot be performed since the lot number is unknown.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.
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