medical Class II Updated 2023-12-13

Staar Surgical Company recalls EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic

Recalled Product

EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic 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: Serial Number/UDI: S1723954/(01)00841542122061(11)221101(17)240930(21)S1723954; S1723955/(01)00841542122061(11)221101(17)240930(21)S1723955;
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