medical Class II Updated 2023-12-13

Staar Surgical Company recalls EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phaki

Recalled Product

EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.


Hazard / Issue

Their is a potential that intraocular implant devices may not meet specifications.

Issued by

FDA

Affected States: AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI
Lot/Code Info: T1438478/ (01)00841542118378(11)230331(17)250228(21)T1438478; T1224985/ (01)00841542118316(11)221026(17)240930(21)T1224985; T1259704/ (01)00841542118330(11)221126(17)241031(21)T1259704; T1370322/ (01)00841542118347(11)230218(17)250131(21)T1370322; T1508546/ (01)00841542118644(11)230518(17)250430(21)T1508546; T1299195/ (01)00841542118149(11)221231(17)241130(21)T1299195
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