Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 3261518, 3272335, 3278550, 3292632, 3305153, 3326272, 3331632, 3334880, 3344465, 3348295, 3350319, 3357568, 3362608, 3363639
  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:
Beaver Visitec International, Inc.
Reason for Recall:
Kit packaging may have small holes compromising product sterility
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884

Product Codes/Lot Numbers:

Lot Numbers: 3261518, 3272335, 3278550, 3292632, 3305153, 3326272, 3331632, 3334880, 3344465, 3348295, 3350319, 3357568, 3362608, 3363639

Distribution:

Distributed in: CA, CO, LA, MA, MD, ND, PA, TN, UT

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0409-2022

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