Recall Z-1925-2024— Alcon Research LLC
Class II · Ongoing
Class II FDA medical device recall by Alcon Research LLC, initiated 2024-04-22. It names one FDA 510(k) clearance: K110166. Product: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A. Reason: 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..
- Recalling firm
- Alcon Research LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-22
- Firm location
- Fort Worth, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 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 Corneal/Scleral V-Lance Ophthalmic knives.
Data sourced from openFDA. This site is unofficial and independent of the FDA.