🔍 RecallPedia

EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.

Class I - Dangerous
🏥 Medical Devices Recalled: September 29, 2023 Staar Surgical Company Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Number/UDI: S1723954/(01)00841542122061(11)221101(17)240930(21)S1723954; S1723955/(01)00841542122061(11)221101(17)240930(21)S1723955;
  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: VICMO13.2. Phakic Intraocular lens.

Product Codes/Lot Numbers:

Serial Number/UDI: S1723954/(01)00841542122061(11)221101(17)240930(21)S1723954; S1723955/(01)00841542122061(11)221101(17)240930(21)S1723955;

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0469-2024

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