medical Class II Updated 2023-12-13

Staar Surgical Company recalls EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phak

Recalled Product

EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. 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: T1210975/ (01)00841542114141(11)221015(17)240930(21)T1210975; T1283082/ (01)00841542115506(11)221212(17)241130(21)T1283082; T1359541/ (01)00841542115544(11)230210(17)250131(21)T1359541; T1377771/ (01)00841542115469(11)230223(17)250131(21)T1377771; T1443561/ (01)00841542115537(11)230403(17)250331(21)T1443561; T1226995/ (01)00841542114615(11)221029(17)240930(21)T1226995; T1365648/ (01)00841542115506(11)230214(17)250131(21)T1365648; T1255982/ (01)00841542115247(11)221120(17)241031(21)T1255982; T1555552/ (01)00841542114776(11)230621(17)250531(21)T1555552; T1187773/ (01)00841542115209(11)220926(17)240831(21)T1187773; T1235414/ (01)00841542114530(11)221106(17)241031(21)T1235414; T1210808/ (01)00841542114349(11)221015(17)240930(21)T1210808; T1195554/ (01)00841542115384(11)221003(17)240930(21)T1195554; T1373152/ (01)00841542114981(11)230220(17)250131(21)T1373152; T1566889/ (01)00841542114950(11)230629(17)250531(21)T1566889
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