Model Number ZXR00 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Visual Disturbances (2140); Halo (2227); 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.Best estimate of date of event is between (b)(6) 2018 and (b)(6) 2019.(b)(4).Device evaluation: product testing could not be performed because the product was not returned.The complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no similar complaints were received from this production order.Conclusion: 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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Event Description
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It was reported that a zxr00 intraocular lens (iol) was implanted in 2018.The patient developed complaint of rings, inability to drive at night.Various glasses/contact lenses tried to resolve the issue but without success.The zxroo lens was explanted and was replaced with a monofocal lens.This report captures the event for the left eye.A separate report is being submitted for the right eye.Follow-up noted that no product is coming back for this event.The contact person doesn't know date of when the visual issues 1st occurred.However, the contact person confirmed that there was no incision enlargement, no vitrectomy and no sutures performed.Patient was well post-op.No other information was received.
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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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