No data regarding product identity were indicated for the event; therefore, the device history record (dhr) could not be reviewed.No sample was returned; therefore, the condition of the product could not be verified.Because a sample was not returned and no lot number was indicated for this complaint, the root cause cannot be determined.The directions for use (dfu) for this product states: pfo must be completely removed at the conclusion of the procedure by aspiration through either a 23 gauge or flute needle during the air-fluid exchange, or by direct exchange with an appropriate long-term vitreous substitute.Failure to remove may result in visual abnormalities and secondary surgical intervention.(b)(4).
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In a literature article information was presented with regard to a retrospective study of a cluster of six cases of retained intraocular perfluoron (pfo) that occurred after pars plana vitrectomy (ppv) for retinal detachment repair.Pfo was noted in the anterior chamber (ac) and/or vitreous and removed with ac paracentesis, ac wash-out, and/or ppv.These cases were noted shortly after the facility transitioned from non-valved trocar cannulas to valved trocar cannulas between may 16, 2012 through january 7, 2013.This is the fourth of six reports.Reference: oellers p, schneider e, fekrat s, mahmoud t, mruthyunjaya p, hahn p.Retained intraocular perfluoro-n-octane after valved cannula pars plana vitrectomy for retinal detachment.Ophthalmic surg lasers imaging retina.2015; 46: 451-456.
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