Model Number 1MTEC30 |
Device Problem
Failure to Eject (4010)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Lot number: unknown, not provided.Expiration date: unknown, as lot number was not provided.Catalog#: a complete catalog number is unknown as the lot number was not provided.Udi#: a complete udi # is unknown as the lot number was not provided.Device manufacture date: unknown, as lot number was not provided.Attempts have been made to obtain missing information; however, to date a response has not 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 advance of the intraocular lens (iol) it became stuck in the cartridge.Apparently the tech had an issue with loading the lenses, same patient.One of the lenses had patient contact and one did not.No further information was provided.
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Manufacturer Narrative
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Device available for evaluation?: yes, returned to manufacturer on 06/19/2019.Device returned to manufacturer?: yes.Device evaluation: the model zcb00 lens packaging box was received.Inside was a cartridge with a lens positioned in the loading zone.The cartridge was observed under microscope and viscoelastic residue was not observed inside the cartridge.The haptics were observed not folded.The complaint was not verified since the lens was observed positioned in the loading zone and not stuck as reported.A product quality deficiency was not identified.Manufacturing record review: a review of the records was performed.The lens was manufactured according to specification.There was no indication of a product malfunction or product quality deficiency.A search on complaints revealed that no other complaint has been received for this production order number.Based on the results of the investigation, no product deficiency was identified.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 (b)(4) and capa-010215.
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Search Alerts/Recalls
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