Model Number ZA9003 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Type
Injury
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Manufacturer Narrative
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Date of event: unknown, not provided.Best estimate of date of event is between (b)(6) 2020 and (b)(6) 2020.Device evaluation: product evaluation was not performed because the product has not yet been received.If product is received after initial closure, the ir and complaint file (if necessary) may be re-opened to complete the return investigation.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Event Description
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It was reported that the lens was explanted from patient left eye due to unhappy with post-op outcome.There was incision enlargement.No sutures or vitrectomy were required.Lens was implanted with a non-johnson and johnson lens, 14.0diopter power as replacement.No further information provided.
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Manufacturer Narrative
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Additional information: section d10: device available for evaluation ¿ yes, returned to manufacturer on 1/25/2021 section h3: device returned to manufacturer ¿ yes.Device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, which is consistent with a lens that was handled during explant.The lens was cleaned, and no cosmetic issues were observed.The complaint issue could not be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.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 and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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