Alcon Research, LLC: Custom Surgical Procedure Packs Recalled for Mislabeled Latex-Free Status

Agency Publication Date: November 7, 2023

Summary

Alcon Research, LLC is recalling 120 Alcon Custom-Pak Surgical Procedure Packs (REF 14057-09) used for cataract surgeries. These packs are incorrectly labeled as "latex free" despite containing gloves that are made with natural rubber latex. This mislabeling could lead to healthcare providers using these packs on patients with severe latex allergies without realizing the risk.

Risk

The use of these packs on individuals with a latex sensitivity or allergy can cause a serious allergic reaction, including anaphylaxis, which can be life-threatening if not treated immediately.

What You Should Do

Check your surgical inventory for Alcon Custom-Pak Surgical Procedure Packs with REF 14057-09 and Lot Number 160NMU.
Verify the UDI (Unique Device Identifier) code (01)10380653302278 located on the product packaging to confirm if your supply is affected.
Immediately stop using any affected packs and sequester them to ensure they are not used in surgeries involving patients with known latex allergies.
Contact Alcon Research, LLC or your medical facility's procurement department for specific instructions regarding the return or replacement of these mislabeled packs.
Contact your healthcare provider or Alcon Research, LLC directly at their Houston facility (9965 Buffalo Speedway, Houston, Texas) for further instructions and potential refund information.
Report any adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program at 1-800-FDA-1088 or www.fda.gov/medwatch.
Contact the FDA medical device recall hotline at 1-888-463-6332 for additional questions.

Your Remedy Options

Other Action

Manufacturer notification and corrective action

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Alcon Custom-Pak, Surgical Procedure Pack (45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR)

Model / REF:

REF 14057-09

UPC Codes:

10380653302278

Lot Numbers:

160NMU

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93115

Status: Active

Manufacturer: Alcon Research, LLC

Sold By: N VIRGINIA EYE SURG CTR

Manufactured In: United States

Units Affected: 120 packs

Distributed To: Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your surgical inventory for Alcon Custom-Pak Surgical Procedure Packs with REF 14057-09 and Lot Number 160NMU.

Verify the UDI (Unique Device Identifier) code (01)10380653302278 located on the product packaging to confirm if your supply is affected.

Immediately stop using any affected packs and sequester them to ensure they are not used in surgeries involving patients with known latex allergies.

Contact Alcon Research, LLC or your medical facility's procurement department for specific instructions regarding the return or replacement of these mislabeled packs.

Contact your healthcare provider or Alcon Research, LLC directly at their Houston facility (9965 Buffalo Speedway, Houston, Texas) for further instructions and potential refund information.

Report any adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program at 1-800-FDA-1088 or www.fda.gov/medwatch.

Contact the FDA medical device recall hotline at 1-888-463-6332 for additional questions.