Recall Z-1922-2024

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.

FDA-determined cause: Process control

Action taken

On April 22, 2024 VOLUNTARY MEDICAL DEVICE FIELD CORRECTION letters to customers. Actions to be taken by the Customer / User: If a knife does not perform as expected, or if you feel it does not meet your expectation for sharpness, discontinue use of that specific knife and replace the knife with a new one to avoid potential complications. To acknowledge your receipt of this Voluntary Medical Device Correction notification, please take the following steps: 1. Forward this notification to all departments or organizations using Alcon Ophthalmic Knives. 2. Follow the risk mitigation precautions provided in this notice when using identified catalogue numbers of ophthalmic knives. 3. Please complete the attached Response Form indicating your understanding of the included instructions and return the attached Response Form via email or fax to Alcon. Email: Market.Actions@alcon.com Fax: 817-302-4337 Alcon has reported this issue to Health Authorities in accordance with applicable regulations. 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). Adverse events or quality problems experienced with the use of this product may also be reported to the FDA MedWatch Adverse Event Reporting program either online (FDA EMAIL), by regular mail or by fax: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm. Should you have any questions or concerns about this matter or need help finding a replacement or substitute sterile standalone ophthalmic surgical knife, please call Alcon Customer Service or contact your Alcon Sales Representative.