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Model Number 1MTEC30 |
Device Problems
Failure to Eject (4010); Physical Resistance/Sticking (4012)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/24/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Lot #: unknown,not provided.Expiration date: unknown as lot number was not provided.Unique identifier number (udi#): a complete udi# is unknown as the lot# was not provided.If implanted, if explanted, give date: not applicable, cartridge is not an implantable device.Expiration date: unknown as lot number was not provided.Device evaluation: it was confirmed that only the suspect lens was returned.Since cartridge is not available, the complaint issue reported could not be verified.Product deficiency could not be determined.Manufacturing record review could not be performed since lot number is unknown.The complaint occurrences per lot/batch also could not be performed since lot number is unknown.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Attempts have been made to obtain missing information; however, no definitive response has been received.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 during insertion of a model zlb00 intraocular lens (iol), the lens got stuck in the 1mtec30 cartridge.It was stated that there was patient contact.Through follow-up it was learnt that the lens was partially delivered into the eye, and then it got stuck in the cartridge.There was no incision enlargement, vitrectomy, or sutures required.Only the iol involved in the event is being returned, not the cartridge.The patient is reported to be fine, surgery went well post-op.No other information was 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 (b)(4) and capa-010215.
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Search Alerts/Recalls
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