Model Number ZA9003 |
Device Problems
Break (1069); Inaccurate Delivery (2339)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/05/2022 |
Event Type
malfunction
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Event Description
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It was reported that an intraocular lens (iol) was partially inserted in patient's right eye, pinched trailing haptic.No report of other adverse events.No other information was provided.
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Manufacturer Narrative
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Age, weight, ethnicity: unknown/ not provided.Date of event: unknown, not provided.If implanted, give date: not applicable, as lens was not implanted if explanted, give date: not applicable, as lens was not implanted, hence not explanted.The device is not returned; therefore, a failure analysis of the complaint device cannot be completed.A review of the device record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Manufacturer Narrative
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Additional information: follow-up information received that date of event was dec.5, 2022.Patient was fine post-op.Got a new iol without any difficulty.Field below updated: section b2: date of event: dec.5, 2022.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Manufacturer Narrative
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Corrected data: in review, it was noted that the "g4" field which should have been populated with "no" was inadvertently left blank in the initial mdr report; therefore, the information has been corrected in this supplemental mdr report and the field below has been updated accordingly: section g4: combination product: no.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Manufacturer Narrative
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Section d9.Device available for evaluation? yes.Returned to manufacturer on: 1/20/2023.Section h3.Device evaluated manufacturer? yes.Device evaluation: product evaluation was performed under magnification.The complaint lens presented with a chipped edge, haptic bent, and cosmetic issues from being crushed in the lens insert.The complaint issue dc-haptic damaged was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Dc-delivery issues and the other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.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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