Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 1792733H, 1783925H, 1785227H, 1786729H
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Alcon Research, Ltd.
- Reason for Recall:
- The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
Product Codes/Lot Numbers:
1792733H, 1783925H, 1785227H, 1786729H
Distribution:
Distributed in: VT
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0195-2016
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Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
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Class I - Dangerous
Potential for a weak seal in some units resulting in compromise in sterility.
Due to incomplete seals in the pouch which provide the sterile barrier.