🔍 RecallPedia

Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient

Class I - Dangerous
🏥 Medical Devices Recalled: October 12, 2016 Bausch & Lomb Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    LOT #(s) AND EXPIRATION DATES, SERIAL #(s), ORDER #, or OTHER IDENTIFICATION #(s): SKU E0815 A, SKU E0815 B, SKU E0815 0.5, SKU E0815 1.0 and SKU E0816 C
  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:
Bausch & Lomb, Inc.
Reason for Recall:
According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of SKU 0816 C (Pterygium Burr Medium Diamond). Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction. Therefore Bausch & Lomb is proposing a Field Correction to provide customer purchasing product from April 30, 2012 to June 20, 2016 with the current operating instruction.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient

Product Codes/Lot Numbers:

LOT #(s) AND EXPIRATION DATES, SERIAL #(s), ORDER #, or OTHER IDENTIFICATION #(s): SKU E0815 A, SKU E0815 B, SKU E0815 0.5, SKU E0815 1.0 and SKU E0816 C

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0983-2017

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