Model Number ZCB00 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Eye Injury (1845)
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Event Type
Injury
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Manufacturer Narrative
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Device evaluated by mfr: 81 - other: the device is not returned; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.An attempt has been made to obtain missing information; however, no definitive 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 an intraocular lens (iol) zcb 22.0 does not have any paperwork that was sent with it, however it was in a biohazard bag, implying customer contact and that lens was explanted.No other information was provided.
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Manufacturer Narrative
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Additional information: section d9.Device available for evaluation? yes.Returned to manufacturer on: dec 21, 2022.Section h3.Device evaluated manufacturer? yes.Device evaluation: visual inspection under magnification revealed that the complaint lens was received coated in viscoelastic residue.The lens was cleaned and, no issues that could cause or contribute to the complaint issues.The complaint issue was not confirmed; therefore, there is no indication of a product deficiency or product malfunction.Corrected data: further follow-up confirmed that for this suspect lens, there was truly no product quality issue.Lens being returned in a biohazard bag because it was either dropped on the floor and customer only returning for replacement.No patient contact.Therefore, event this time is being assessed as not reportable.Therefore, there will no longer be any further reporting under mfr report number 3012236936-2022-03152.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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