Model Number 1MTEC30 |
Device Problem
Material Separation (1562)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/14/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If implanted; give date: n/a (not applicable).The cartridge is not an implantable device.If explanted; give date: n/a (not applicable).The cartridge is not an implantable device; therefore, not explanted.Attempt has been made to obtain additional information; however, to date a response has not been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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Event Description
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A report was received that a piece of plastic from a 1mtec30 cartridge broke off and entered the anterior chamber of the patient's eye while inserting the lens.The surgeon was able to remove the plastic piece and the posterior bag was still okay.It was also noted that there was no secondary intervention required such as; vitrectomy, suture, and incision enlargement.A zcb00 intraocular lens was used with the cartridge and remains implanted.No additional information was provided.
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Manufacturer Narrative
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Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Photographic evaluation: the cartridge was not returned, however, a photo was provided and evaluated.The cartridge tip was observed broken (missing part).The complaint issue of debris was not confirmed, however, tip deformed in the cartridge was confirmed.As the actual product was not returned; a thorough evaluation was not possible to confirm if the condition reported was related to manufacturing practices/process.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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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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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