Received a voluntary event report from fda: # mw5089673.The patient reported on (b)(6)2019, a "serious injury" report with outcome of "disability/permanent damage".The patient stated "got visian icl plastic lens implants in both eyes.In left eye over a year later i had symptoms of foggy vision, new floaters and today my vision is almost gone.There's a huge blob of water blocking my sight.When i move my eye i can see the water move." per the same report concomitant medical products listed as: "alphagan and prenatal vitamins", with patient problems of: "impaired vision, vitreous floaters" and device problems: "adverse events without identified device or use problem" was reported.Per patient email of 30 sep 2019 "visian icl was removed on the left eye (b)(6) to prepare for vitrectomy for retinal detachment repair".Information received from the implanting surgeon indicated that a 13.2mm, micl13.2, -16.00 diopter, implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2017 and removed on (b)(6) 2019.Loss of bcva, lens opacity (ns), retinal detachment, blurred vision, and floaters was observed.Additional surgical intervention/treatment (prk, icl removal + ce/iol, retinal repair) were performed.On patients last visit on (b)(6) 2019, the patients bcva was 20/80-, ucva 20/200.Clear cornea, superior pi, pc/iol with mild to moderate pco, s/p vitrectomy, 45 % gas, and retina attached was reported for status of the eye (signs/symptoms).Per retinal detachment repair surgeon and icl removal and cataract surgery surgeon this incident did not involve an adverse event related to the visian icl.If additional information is received a supplemental medwatch report will be submitted.
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