Model Number VTICMO12.6 |
Device Problem
Device Handling Problem (3265)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
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Event Date 09/20/2016 |
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).Lens explanted and exchanged for a lens the same size, model, but a different diopter.(b)(4).
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Event Description
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The reporter indicated that the surgeon implanted a 12.6 mm vticmo12.6 implantable collamer lens, -7.0/2.5/092 diopter in the patient's right eye (od) on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to the lens was implanted inside out.The lens was exchanged for a lens the same model, size but a different diopter and the problem was resolved.
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Manufacturer Narrative
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Device evaluation: lens was returned dry in lens case/vial with clear surgical residue/debris on product.Visual inspection found haptic broken.(b)(4).
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Manufacturer Narrative
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Additional information: work order search: no similar complaints were reported for units within the same lot.(b)(4).
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Search Alerts/Recalls
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