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Model Number 1MTEC30 |
Device Problems
Difficult or Delayed Positioning (1157); Positioning Failure (1158)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Lot: unknown, not provided.Udi: unknown, as the lot number was not provided.Expiration date: unknown, as the lot number was not provided.If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an implantable device.Unknown, as the lot number was not provided.Attempts have been made to obtain missing information; however, to date no response has been received.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 the during insertion into the patient's operative eye of the intraocular lens (iol), model zcb00 +23.5 diopter, the iol did not fully come out of the inserter.Reportedly, the iol was inserted partially and removed.Another lens, same model and diopter, was implanted as a replacement.No further information was provided.
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Manufacturer Narrative
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Corrected data: in the initial report 2648035-2018-00700, the concomitant product was inadvertently not populated with the intraocular lens details.Zcb00 lens, serial number (b)(4) should have been entered.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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Manufacturer Narrative
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Device evaluation: the cartridge was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the lot number is unknown, therefore the manufacturing records could not be reviewed.Labeling review: the directions for use (dfu) were reviewed.The directions for use (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 and johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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