Model Number ZCT300 |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Code Available (3191)
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Event Date 06/11/2020 |
Event Type
Injury
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Manufacturer Narrative
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Sex/gender: unknown/ not provided.If explanted; give date: not applicable as the lens remains implanted.(b)(6).(b)(4).Device evaluation: the product testing could not be performed as the product remains implanted.The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed no other complaints have been received for this production order number.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 a day after implantation, the surgeon observed the toric model intraocular lens was rotated 30 degrees counterclockwise.The lens was repositioned in a second surgery to place the iol again in the right position.Post-repositioning, the patient's outcome is reported as okay.No 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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