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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Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2018 and (b)(6) 2018.(b)(4).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 10.0 diopter lens was implanted in the patient's operative eye on (b)(6) 2018.It was later explanted on (b)(6) 2018 because the lens originally implanted was the wrong lens diopter power.There was no incision enlargement, no vitrectomy, and no sutures used.No additional information was provided.
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Manufacturer Narrative
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Device available for evaluation: yes.Returned to manufacturer on: 10/29/2018.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.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 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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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 (b)(4), and capa-010215.
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Search Alerts/Recalls
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