Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cataract (1766); Retinal Detachment (2047); No Code Available (3191)
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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).
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Event Description
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An article was received that cited a retrospective clinical study that found 10 patients implanted with the phakic intraocular lens (piol) had developed retinal detachment.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
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Manufacturer Narrative
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A journal reports 10 cases of retinal detachment, one cataract, one case requiring multiple surgeries.And two explants associated with unknown model piols.Anatomical success with visual improvement was achieved in all 10 eyes.It is not known if all the lenses in the study were manufactured by staar or if it included lenses manufactured by other companies.(b)(4).Claim#: (b)(4).
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Manufacturer Narrative
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The reporter indicated they have concluded that the incidence of retinal detachment in eyes with phakic iol is no more than the natural history of the disease (myopia).No more information was available.(b)(4).
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Search Alerts/Recalls
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