Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: M

FDA device recall Z-0835-2025 · posted 2025-01-10 · Open, Classified

Recall details

Recalling firm

Alcon Research LLC

Reason for recall

Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery.

Action taken

On 11/13/2024, Alcon Laboratories, Inc. issued a "Urgent: Medical Device Field Correction" to affected consignees. Alcon asked consignees to take the following actions: 1. See Table 1 for list of affected of Monarch III D delivery cartridges distributed to your facility. 2. Review your Monarch III D delivery cartridge inventory to determine if you have any remaining units from the identified lots. 3. If you have remaining units from the identified lots, please dispose of all impacted lots of Monarch III D delivery cartridges identified in Table 1. Please contact Alcon Customer Service to arrange for replacement of Monarch III D delivery cartridges. 4. Please confirm quantity destroyed by including on response form, even if you have zero units remaining in inventory. 5. Forward this notification to professionals within your organization who may be using the identified of Monarch III D delivery cartridges, and to all departments or organizations to which identified lots of Monarch III D delivery cartridges lots may have been transferred. 6. Respond to Alcon indicating your understanding of the included instructions by completing our online response form at https://qrco.de/Monarch-Response or by completing the attached Response Form and returning to Alcon via email or fax. 7. In the event you have experienced adverse events or product quality issues related to this communication, please contact Alcon via web (https://notifeye.alcon.com), by email (msus.safety@alcon.com) or by phone (1-800-757-9780) Monday through Friday, 8:00 AM to 5:00 PM, Central Time. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA MedWatch Adverse Event Reporting program: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.

Root cause

Process design

Status

Open, Classified

Product code

KYB

Quantity affected

41718 units

Distribution

US: AK AL AR AZ CA CO CT DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY OUS: Russia, Egypt

Date initiated

2024-11-13

Date posted

2025-01-10

Location

Fort Worth, TX

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