Model Number VICMO13.7 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problems
Obstruction/Occlusion (2422); No Code Available (3191)
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Event Date 01/31/2016 |
Event Type
Injury
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Manufacturer Narrative
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This product is manufactured in the u.S.But is not marketed in the u.S.(b)(4).
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Event Description
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The reporter indicated that the surgeon implanted a 13.7 mm vicmo13.7 implantable collamer lens, -14.0 diopter in to the patient's right eye (od) on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to excessive vault.The lens was exchanged for a shorter lens and the problem was resolved.The patient's post-op best corrected visual acuity was 20/20.
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Manufacturer Narrative
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Device evaluation: product evaluation found that the lens was returned in liquid and in the lens case/vial.Visual inspection found the lens haptic torn/ broken/ bent/ deformed.Work order search: no similar complaints were reported for units within the same lot.Conclusion: the patient is under the age of 21 years.(b)(4).
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Search Alerts/Recalls
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