Model Number 1MTEC30 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/06/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This is not an implantable device.Device manufacture date: unknown as the lot number was not provided.Note: two lot numbers were provided but it is unknown which one was used in this event.Lot cc04219, (b)(4), lot cc04220, (b)(4).All pertinent information available to abbott medical optics has been submitted.
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Event Description
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It was reported that after the insertion into the eye of an intraocular lens (iol) a silver material was observed on the posterior side of the lens.Reportedly, the foreign material was believed to come from inside the cartridge.No further information was provided.
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Manufacturer Narrative
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(b)(6).Gender/sex: female.Lot number: cc04219.Expiration date: 04/07/2018.(b)(4).Concomitant medical products: zcb00 22.5 diopter intraocular lens sn (b)(4).Device manufacture date: 04/07/2017.Additional information received reported the patient is female with a (b)(6).Also, the intraocular lens was a zcb00 22.5 diopter intraocular lens (iol).The description of the silver material was further clarified as a clear, film-like substance and that it was removed through irrigation and aspiration with no other detrimental intra- or post-operative effects noted.The lot number for the cartridge was clarified as cc04219.The intraocular lens remains implanted.There was no incision enlargement, vitrectomy, sutures used, or patient injury.The patient's outcome is good and there are no post-operative adverse events.No additional information was provided.Device evaluation: the cartridge was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the cartridge was reviewed.The product was manufactured and released according to specification.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 abbott medical optics has been submitted.
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Manufacturer Narrative
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Corrected data: in review of mdr supplement report #1, it was noted that the patients date of birth was incorrect.The following section has been updated accordingly: date of birth: (b)(6).All pertinent information available to abbott medical optics has been submitted.
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Search Alerts/Recalls
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