Z-2652-2024 Class II Ongoing

Recalled by Alcon Research LLC — Fort Worth, TX

FDA device recall Z-2652-2024 was initiated by Alcon Research LLC on Jul 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: 29,814 units.

Recall Details

Product Type
Devices
Report Date
Aug 28, 2024
Initiation Date
Jul 15, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
29,814 units

Product Description

Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Number: 8065772445 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: 8065772445; UDI-DI: 00380657724451; Lot numbers: 15V018, 15V019, 15V01A, 15V01C, 15V01D, 15V036, 15W7UE, 15W7UF, 15W7UH, 15W7UJ, 15W996, 15W997, 161960, 161961, 161962, 161963, 167PR0, 167PT9, 168NM5, 168NM6, 168NM7, 168NN9, 168NNA, 168NNC, 168YFW, 169KL0, 169KL1, 169KL2, 169KL3, 169KTC, 169KTE, 169KTH.

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2652-2024
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.