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Model Number 1MTEC30 |
Device Problem
Deformation Due to Compressive Stress (2889)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Lot #: unknown as information was not provided.Expiration date: unknown as product lot number was not provided.Udi #: a complete udi # is unknown as product lot number was not provided.If implanted, give date: not applicable, as the cartridge is not an implantable device.If explanted, give date: not applicable, as the cartridge is not an implantable device.Device manufacture date: unknown, as product lot number was not provided.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 during product handling and prior to insertion of zcb00 23.0 diopter intraocular lens (iol) the haptic was noticed bent and the cartridge was noticed to be damaged before being given to surgeon.It was reported the appropriate cartridge and injector was used, back-up iol was used, and there was no intervention or complications intra-op or post-op.A photograph was received confirming the cartridge tip was damaged.There was no patient contact, no serious patient injury, no medical complications, and there was no surgical intervention.No additional information was provided to johnson & johnson surgical vision.
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Manufacturer Narrative
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Device available for evaluation: yes, returned to manufacturer on: 05/02/2019.Device evaluated by manufacturer: yes.Device evaluation: the complaint product was received in its original packaging with the wheel case insert and a cartridge with no identification.Lubricant material residues were observed in the cartridge.Cartridge tip was damaged/deformed.The reported issue was verified.However, due to the condition in which the sample returned it is not possible to determine that the reported issue is related to the manufacturing process.Based on the analysis product quality deficiency could not be determined.Manufacturing records review: the manufacturing record cannot be reviewed since the cartridge lot number is unknown.Historical data analysis: the complaint history was not reviewed since the cartridge lot number is unknown.Labeling review: the labeling review could not be performed because the complaint product was not identified.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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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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