Alcon Research LLC Aspex Facility ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Brand
Alcon Research LLC Aspex Facility
Lot Codes / Batch Numbers
Model/Catalog Number: 8065771540, UDI/DI: 00380657715404, Lot/Batch: 1668D7, 167PRA, 167PTK, 168NMF, 169KL4, 169KTP, 16ALPE, 16ALTU, 16AV18, 16DDPR, 16DDRU
Products Sold
Model/Catalog Number: 8065771540; UDI/DI: 00380657715404; Lot/Batch: 1668D7, 167PRA, 167PTK, 168NMF, 169KL4, 169KTP, 16ALPE, 16ALTU, 16AV18, 16DDPR, 16DDRU;
Alcon Research LLC Aspex Facility is recalling ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: due to Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Op. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026