Home / Recalls / Alcon Research LLC / Z-2663-2024

Z-2663-2024 Class II Ongoing

Recalled by Alcon Research LLC — Fort Worth, TX

FDA device recall Z-2663-2024 was initiated by Alcon Research LLC on July 15, 2024 and is designated Class II. Reason for recall: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. The recall status is ongoing. Affected quantity: 35,199 units.

Recall Details

Product Type
Devices
Report Date
August 28, 2024
Initiation Date
July 15, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
35,199 units

Product Description

Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992445 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Reason for Recall

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

Distribution Pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

Code Information

Model/Catalog Number: 8065992445; UDI-DI: 00380659924453; Lot numbers: 169P2R, 16AV06, 16AV1Y, 16F1JU, 16K9HA, 167R42.

Other recalls by Alcon Research LLC

  • D-0491-2026 Class II — Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in Fran (April 21, 2026)
  • D-0492-2026 Class II — GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alc (April 21, 2026)
  • Z-0939-2026 Class I — Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Nu (November 24, 2025)
  • Z-0326-2026 Class II — Alcon PRECISION1 One-Day Contact Lenses, -2.25D. (September 30, 2025)
  • Z-0581-2026 Class II — CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ (September 15, 2025)
  • Z-0308-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
  • Z-0306-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
  • Z-0305-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
  • Z-0307-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
  • Z-0304-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)

FDA data resources