Model Number ZXT225 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problems
Visual Impairment (2138); 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 (b)(6) 2018.(b)(4).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 zxt225 21.0 diopter intraocular lens (iol) was implanted in the patient''s right eye (od) on (b)(6) 2018.It was later explanted on (b)(6) 2018 because the patient had poor vision due to the myopic outcome.Reportedly, the patient was too myopic and could not read up close.There was no incision enlargement, no vitrectomy, and no sutures used.The replacement lens was the same model, but different diopter of 19.5.There was no patient injury and the patient is doing fine post-operatively.No additional information was provided.
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Manufacturer Narrative
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Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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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Device available for evaluation: yes.Returned to manufacturer on: 12/20/2018.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 pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.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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