Model Number ZCT |
Device Problem
Unintended Movement (3026)
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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 birth : only year provided 1955.Date of event: exact date unknown/ not provided, best estimate is between (b)(6) 2020 - (b)(6) 2020 (date of lens repositioning procedure).Serial#: unknown/not provided.Model# and catalog#: only partially known.Expiration date: unknown as product serial number was not provided.Udi # is unknown as product serial number was not provided.If explanted; give date: not applicable, lens remains implanted.(b)(6).Device manufacture date : unknown as product serial number was not provided.(b)(4).Device evaluation: the product testing could not be performed as the device remains implanted.The complaint cannot be confirmed.Manufacturing record review: the manufacturing record and complaint history were not reviewed since the serial number is unknown.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 and johnson surgical vision, inc.Has been submitted.
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Event Description
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It was reported that a toric model intraocular lens rotated counterclockwise in the left eye of the patient post implantation, and there was a need to reposition the lens.Additional information was provided, the lens rotation was from 100 to 120 degrees.Repositioning of the lenses was performed in a secondary surgical intervention.Visual acuity pre-operative was 3-4/10 and post-operative visual acuity was 9/10.No patient injury was reported, and additional information provided.
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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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