Model Number VICM5 12.6 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Uveitis (2122); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/22/2023 |
Event Type
Injury
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Event Description
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The reporter indicated that the surgeon implanted a 12.6mm vicm5_12.6.-2.25 diopter implantable collamer lens into the patient's right eye (od) on (b)(6) 2023.Lens was explanted on (b)(6) 2023 due to pigment dispersion and prolonged post-op anterior uveitis.Problem not resolved.Cause of event unknown.Reportedly, anterior chamber activities persist and patient is under gutt pred forte 1%, gutt vigamox, gutt irmocomod, gutt glanatec.
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Manufacturer Narrative
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A4 - unk; a5 - unk; a6 - unk; h6 - health effect clinical code 4581: pigment dispersion.H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
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Manufacturer Narrative
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H6 - work order search: one additional similar complaint type event within associated lots was found (fellow eye (os).Claim # (b)(4).
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Manufacturer Narrative
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H3: device evaluation: the lens was returned dry in a microcentrifuge vial with residue/debris on the lens.Visual inspection found no visible damage with foreign material on the lens surface, specifically residue throughout the lens.Claim#: (b)(4).
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Search Alerts/Recalls
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