Model Number ZXR00 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2018 and (b)(6) 2018.Explant; attempts have been made to obtain missing information; however, to date, no 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 a zxr00 25.5 diopter lens was implanted in the patient's right eye (od) on (b)(6) 2018.It was later explanted on (b)(6) 2018.There was no incision enlargement, no vitrectomy, and no sutures used.The replacement lens was the same model, but different diopter of 24.0.No additional information was provided.
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Manufacturer Narrative
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Device available for evaluation: yes.Returned to manufacturer on: 07/07/2018.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection with the unaided eye shows the product is cut in half, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints were received for this production order number.Labeling review: the labeling review was not reviewed because limited information was received.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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Manufacturer Narrative
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This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.
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Search Alerts/Recalls
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