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Model Number EMERALDC30 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2022 |
Event Type
malfunction
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Event Description
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It was reported that the intraocular lens (iol) was damaged during insertion and customer believes that the issue occurred due to misshapen cartridge.There was contact with patient's operative eye.No other information was provided.
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Manufacturer Narrative
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Patient age, weight and ethnicity: unknown, information not provided.If implanted, give date: not applicable as this is not an implantable device. if explanted, give date: not applicable as this is not an implantable device. the device was not returned for evaluation; 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.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Manufacturer Narrative
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Correction: additional information was received from the patient label received along with the product.As per this new information, following correction is required: section b3: date of event: mar 29, 2022.Additional information: section b5: the eye affected was right eye.Section e1: reported name: dr.(b)(6).Section e2: health professional: yes.Section e3: occupation: physician.Section d9: device available for evaluation? yes.Section d9: returned to manufacturer: yes.Section d9: returned to manufacturer on: jun 14, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the intraocular lens (iol) product was returned to the manufacturing site for evaluation.No complaint cartridge was received as part of this return.Visual inspection under magnification revealed that the lens was received with a cut to the iol.The lens was cleaned and, a chip on the lens could be observed.Cosmetic issues on the edge could be observed as well.The reported complaint issue could not be confirmed and the observed iol torn issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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