Alcon Recalls ClearCut Ophthalmic Knives Due to Reduced Sharpness
Alcon is recalling 15,222 units of ClearCut Slit and A-OK ophthalmic knives due to reports of reduced sharpness. The devices are distributed nationwide and internationally across 45+ countries.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a surgical instrument where reduced sharpness presents a direct risk of harm to surgical precision and outcomes. The product fits the rubric criterion of a risk-of-harm device where injury has not yet been reported, warranting a High severity rating despite the absence of adverse event reports.
Plain-English summary
Alcon Research LLC is recalling 15,222 units of ClearCut Slit Full Handle 3.0MM Ang Dual ophthalmic knives (Model 8065993047) and related A-OK Corneal/Scleral V-Lance surgical instruments due to an increase in complaint reports related to sharpness.
The affected products are identified by lot numbers 1668MH, 16AUYX, and 16DNHX. These instruments have been distributed nationwide in the United States and internationally to more than 45 countries including Canada, UK, Australia, Japan, Germany, and others.
Reduced sharpness in ophthalmic surgical knives may affect surgical precision during eye procedures. Users and healthcare facilities with affected instruments should discontinue use and contact Alcon for further instructions regarding replacement or return.
The recalled product
- Product
- Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Catalog Number: 8065993047 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Manufacturer
- Alcon Research LLC
- Affected units
- 15,222
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model/Catalog Number: 8065993047
- UDI-DI: 00380659930478
- Lot numbers: 1668MH
- 16AUYX
- 16DNHX.
Distribution
Part of a larger recall action
This product is one of 36 recalled by Alcon Research LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 36 products in this recall →Related recalls
Same manufacturer · Alcon Research LLC
See all →- SevereGenTeal Tears Lubricant Eye Gel Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-05-06
- SevereSystane Lubricant Eye Gel Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-05-06
- CriticalOphthalmic surgical packs recalled over incomplete seals affecting sterility
FDA (Devices) · 2025-12-31
- ModerateVitrectomy probe packs recalled with no reason stated in the record
FDA (Devices) · 2025-12-03
- HighVitrectomy probe accessories recalled over incomplete seals in sterile pouches
FDA (Devices) · 2025-11-05
Same hazard · reduced sharpness
See all →- HighOphthalmic Surgical Knives Recalled for Reduced Sharpness in Eye Surgery
FDA (Devices) · 2024-08-28
- HighOphthalmic Surgical Knives Recalled for Potential Sharpness Issues
FDA (Devices) · 2024-08-28