Model Number VICMO12.6 |
Device Problems
Defective Device (2588); Unintended Movement (3026)
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Patient Problems
Pain (1994); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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Weight: unknown.Ethnicity: unknown.Race: unknown.Date rec¿d by mfr: this product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
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Event Description
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The reporter indicated the surgeon implanted a 12.6mm vicmo12.6 implantable collamer lens, -10.00 diopter, in the patients right eye (od), on (b)(6) 2021.The patient was reported with hyperopia and astigmatism, which caused bad and blurred vision.Also reported permanent loss of bcva.The lens was also reported as having flipped.The patient had a small eye, there was pupilar constriction and the pupil began to close during the surgery.The iris got extruded out the wound during the surgery.The lens was explanted and re-implanted on (b)(6) 2021.Peribulbar block was administered during 2nd surgery.The problem was resolved.The cause of the event was unknown.The patient is happy with the results of the surgery.
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Manufacturer Narrative
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Additional information: b5: it was also indicated the patient experienced pain; non conformity that wasn't specified what type; lens was implanted upside down/flipped, lens was explanted on 03-march-2021 and the day after was re-implanted.H6: 4581- loss of bcva, iris prolapse.Claim#: (b)(4).
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Manufacturer Narrative
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It was later clarified that the lens was removed on (b)(6) 2021 and properly reimplanted, intraoperatively and not in a separate surgery.This had resolved the problem.Claim#: (b)(4).
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Search Alerts/Recalls
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