Model Number ZA9003 |
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 Date 03/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Age/date of birth, weight, ethnicity: information unknown/not provided.Date of event: the exact date of event is unknown, not provided, but the best estimate date is (b)(6) 2021.Implant date: if implanted, give date: n/a (not applicable).The intraocular lens was not implanted.Explant date: if explanted, give date: n/a (not applicable).The intraocular lens was not implanted.Therefore, lens was not explanted.Initial reporter first & last name: information unknown/not provided.Phone number: (b)(6).All pertinent information available to johnson and johnson surgical vision has been submitted.
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Event Description
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It was reported that the interior pouch of the device was found to be open, that the customer received a lens that was potentially non-sterile.The procedure was completed successfully with a back-up lens.The was no patient contact as the issue was prior to use.There was no patient injury reported.No further information was provided.
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Manufacturer Narrative
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Additional information/corrected data: additional information received as a result of confirming the sample and contents of the complaint at haneda dc (johnson & johnson surgical vision warehouse in tokyo, japan), the outer box was unopened, only the laminate on the outside of the outer box was torn.It is haneda dc center in japan that winds this laminate.Therefore, the initially reported complaint issue of "sterility assurance concern" does not apply to this case.Therefore, based on the new information received the event is no longer reportable and no further information will be provided under this manufacturer report number 2648035-2021-07524.Device evaluation: although the device was not returned to manufacturing site; as per information received from haneda dc, the complaint issue of packaging was confirmed with the sample evaluation, there was no breach of sterility.The outer box was unopened, only the laminate wrap on the outside of the outer box was torn.It is haneda dc that winds this laminate.Based on the product evaluation results, (b)(4) was initiated for haneda dc to further investigate this complaint issue.Manufacturing record evaluation: the manufacturing records for the device were reviewed and no non-conformance report (ncr) was found.The product was manufactured and released according to specifications.A search in complaint system revealed no other complaints have been received for this production order number.Conclusion: based on the product evaluation results, although, the reported "packaging issue" was confirmed; however, the initial report of 'sterility assurance concern' does not apply to this event.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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