EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Staar Surgical Company
Reason for Recall:
Their is a potential that intraocular implant devices may not meet specifications.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.

Product Codes/Lot Numbers:

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

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0471-2024

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