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Model Number DIU300 |
Device Problems
Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Age or dob, weight, ethnicity: unknown, information not provided.Date of event: unknown, not provided, but the best estimate date is during 2021.If implanted, give date: not applicable, as there is no indication that the lens was implanted.If explanted, give date: not applicable, as there is no indication that the lens was implanted therefore it was not explanted.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 two preloaded intraocular lenses (iols) were sterile compromised as the packaging was not fully intact.One of the lens package had a little hole by the knob and the other was completely ripped at the fold by the knob.The devices were not damaged.However, one box looked like it might have been damaged during shipping, but the serial number of the box could not be confirmed.There was no patient contact with the lenses.Through follow-up, it was clarified that the sterile pouch was damaged on both iols.The box was damaged on just one of the lens.No further information was available.This report captures one of the lens and a separate report is being submitted for the other lens.
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Manufacturer Narrative
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Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 11/10/2021.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Sample was received in its folding carton package with labels patient card and implant card.Folding carton box was observed damage/broken.A puncture was observed in the sealed pouch containing the complaint handpiece and iol.The complaint issue was confirmed, however the complaint issue was further investigated by añasco manufacturing sme, who determined that based on the return condition of the product it is possible that these boxes and pouches were damaged and broken during shipping, and therefore cannot be confirmed to be related to manufacturing and no product deficiency could be identified.There is no information of the shipping box and if it was damaged during shipment by the carrier.Based on the incomplete information, no device code investigation can be performed.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed no additional complaints from this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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