Additional information: additional information received indicated that surgical interventions, intraocular lens (iol) exchange by flange intrascleral haptic fixation and anterior vitrectomy were involved.The following field was updated accordingly: section h6: additional patient code: 2643 - vitrectomy.Section d10.Device available for evaluation? yes; returned to manufacturer on: 10/21/2020 section h3.Device returned to manufacturer? yes.Device evaluation: the complaint lens was received in an unknown solution inside a specimen cup.Additional documentation was received as well.The lens was cleaned and visual inspection under magnification revealed that the lens was received cut in half, which is consistent with a lens that was handled during explant.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated, and no deviation or nonconformance was found during process related to the complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system revealed that no other complaints have been received for this production order number.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 has been submitted.
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