Model Number VICMO12.6 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/26/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This product is manufactured in the u.S.But not marketed in the u.S.No 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 the surgeon removed a 12.6mm vicmo12.6 implantable collamer lens, -13.00 diopter, from the vial and noted the lens was particularly soft and could not spread in the bss.The lens was not implanted in the patients eye.The cause of the event was due to the device.
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Manufacturer Narrative
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H3: device evaluation: the lens was returned in a micro-centrifuge vial, with moisture on lens.Visual inspection found no visible damage to the lens.H6: device history record (dhr) review: based on the results of the investigation all released devices from the associated work order(s) including the suspected device; have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.(b)(4).
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Search Alerts/Recalls
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