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 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.(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 zxt150 24.0 diopter intraocular lens was implanted in the patient's left eye on (b)(6) 2018.It was later explanted on (b)(6) 2018 due to a myopic surprise and the patient being unhappy with the lens.There was no incision enlargement, no vitrectomy, and no sutures used.The replacement lens was the same model, but different diopter of 22.0.Reportedly, 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 available for evaluation; returned to manufacturer on: 02/20/2019.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection using microscope magnification was performed: the returned zxt150 sample was received with the lens cut.The condition observed is consistent with a lens that has been explanted.The complaint issue reported as myopic was not confirmed and due the condition of the zxt150 lens received the complaint could not be related to the manufacturing process; therefore, a product quality deficiency was not identified.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 additional 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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