ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Descripti

FDA device recall Z-1923-2024 · posted 2024-05-30 · Open, Classified

Recall details

Recalling firm

Alcon Research LLC

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.

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.

Root cause

Process control

Status

Open, Classified

Product code

HNN

Quantity affected

427,764 units

Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece,

Date initiated

2024-04-22

Date posted

2024-05-30

Location

Fort Worth, TX

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