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 Date 08/16/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).All pertinent information available to johnson and johnson vision has been submitted.
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Event Description
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It was reported that the tecnis symfony multifocal intraocular lens (model zxr00, +18.5 diopter) was explanted from the patient¿s right eye because the patient was not happy with her vision.The replacement lens was the same model, a zxr00 +11.5 (smaller) diopter.Patient was doing well post op.There was no incision enlargement, no vitrectomy, and no other medical intervention was performed during the procedure.No further information was provided.
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Manufacturer Narrative
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Device available for evaluation: yes.Returned to manufacturer on: 10/16/2018.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 nr-0148919 and capa-010215.
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Search Alerts/Recalls
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