Model Number VICMO12.1 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Code Available (3191)
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Event Date 10/10/2018 |
Event Type
Injury
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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.(b)(4).
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Event Description
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The reporter indicated the surgeon implanted a 12.1mm vicmo12.1 implantable collamer lens, -16.00 diopter, in the patient's right eye (od) on (b)(6) 2018.The lens was explanted on (b)(6) 2018 due to low vaulting.The lens was exchanged for a longer lens and the problem was resolved.The reporter indicated the cause of the event was unknown.
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Manufacturer Narrative
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Device evaluation: lens was returned in a micro-centrifuge vial with moisture on lens.Visual inspection found no visible damage to lens surface.Claim# (b)(4).
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Manufacturer Narrative
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Device evaluation: previous lens reported in supplemental mdr#1 did not match the lens of the original report.The original report stated a complaint against a sphere lens.The lens that was returned from customer was a toric lens which was the incorrect lens.Claim# (b)(4).
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Search Alerts/Recalls
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