JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS
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Model Number PCB00 |
Device Problem
Premature Activation (1484)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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If implanted, give date: not applicable, as the lens was not implanted.If explanted, give date: not applicable, as the lens was not implanted, therefore, it was not explanted.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 an intraocular lens (iol), and haptic was coming out of the cartridge too quickly.The lens came in contact with the patient prior to insertion.There was no vitrectomy, incision enlargement or sutures required.There was no patient injury.No additional information was provided to johnson & johnson surgical vision.
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Manufacturer Narrative
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Device evaluation: product testing could not be performed because the product was not returned.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search of complaints revealed that two (02) additional complaints were received from this production order for dc-stuck in cartridge; these complaints meet the criteria for no further investigation per johnson & johnson surgical vision complaint handling procedures.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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