Model Number VICMO12.6 |
Device Problem
Incomplete or Missing Packaging (2312)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/17/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This product is not marketed in the us.Result: work order search performed, one similar complaint was reported for units within the same lot.(b)(4).
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Event Description
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The reporter indicated that the surgeon implanted a 12.6mm vicmo12.6 implantable collamer lens in the patient's eye on (b)(6) 2017.The surgeon found that the serial number label on the lens case ((b)(4)) didn't match the serial number label on the outside of the box ((b)(4)).Lens remains implanted, will not be returned.Reference mdr 2023826-2017-00411.
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Manufacturer Narrative
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Date of event on initial report is incorrect; correct date is unknown the reporter indicated that the surgeon implanted a 12.6mm vicmo12.6 implantable collamer lens in the patient's eye on (b)(6) 2017.The surgeon found that the serial number label on the lens case ((b)(4)) did not match the serial number label on the outside of the box ((b)(4)).The lens remains implanted and will not be returned.Reference mdr 2023826-2017-00450.(b)(4).
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Search Alerts/Recalls
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