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WHAT IS THIS?
A Recall is a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.
EVENT
| Type of Event | Recall |
|---|---|
| Recall Numbers | Z-1922-2024, Z-1923-2024, Z-1924-2024, Z-1925-2024 |
| Risk Class | Class 2 |
| Recall Qty | 481,751 Total |
| Classification Date | 2024-05-30 |
| Recall Link | Recall Link |
| Notes/Alerts | 4 total recalls for similar ClearCut Knives |
| Recall 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. |
DEVICE
| Manufacturer | Alcon Research |
|---|---|
| Model Names | ClearCut S Safety Sideport Knife 1.2mm Dual Bevel, ClearCut Sideport Knife Dual Bevel 1.2mm Angled, 20 Gauge V-Lance Knife, ClearCut S Safety Sideport Knife 1.0mm Dual Bevel |
| Model Numbers | 8065771541, 8065921541, 8065912001, 8065771540 |
| Part/Item/Catalog/ REF/Product Number | - |
| Device Description | Ophthalmic Knife |
| Serial Number(s) | N/A |
| Lot #/Exp Date(s) | Various, refer to the specific Recall for that model. |
CUSTOMER/PATIENT ACTIONS
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). 1. Forward this notification to all departments or organizations using Alcon Ophthalmic Knives.
2). 2. Follow the risk mitigation precautions provided in this notice when using identified catalogue numbers of ophthalmic knives.
3). Please complete the 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.
CONTACT INFORMATION
Report any adverse health consequences experienced with the use of this product to Alcon Research. Events may also be reported to the FDA’s MedWatch Adverse Event Reporting program via:
Web: MedWatch website at www.fda.gov/medwatch
Phone: 1-800-FDA 1088 (1-800-332-1088)
Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
