Model Number VICMO13.7 |
Device Problems
Break (1069); Device Operates Differently Than Expected (2913); Torn Material (3024)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/24/2016 |
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.Device evaluated by manufacturer? no - lens not returned.(b)(4).
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Event Description
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The reporter indicated the surgeon inserted a 13.7mm vicmo13.7 implantable collamer lens, -07.00 diopter, and the lens tore/broke during injection into the eye.The lens was removed with no apparent patient injury.The patient's post-op best-corrected visual acuity was 20/20.
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Manufacturer Narrative
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Additional information: device evaluation - the lens was returned dry in a lens case/vial.Visual inspection found the haptic broken.Work order search: no similar complaint was reported for units within the same lot.Corrected data: this is an adverse event, not a product problem.Device code (b)(4) previous codes not applicable, material integrity issue not reported.(b)(4).
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Search Alerts/Recalls
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