Model Number ZXT150 |
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 10/09/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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Event Description
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It was reported that tecnis symfony toric multifocal intraocular lens (model zxt150, +20.0 diopter) was explanted from patient¿s right eye in a secondary procedure.Reportedly, there was a hyperopic miss of 1.83; patient had previous lasik.The replacement lens was a model zxt150, +22.5 diopter lens.Patient was doing fine.No further information provided.
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Manufacturer Narrative
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Device available for evaluation: yes.Returned to manufacturer on: 11/16/2018.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The product was received in a lens case.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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