Recall record at a glance
| Official record | Z-1923-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Alcon Research LLC |
| Report date | Jun 5, 2024 |
| Recall initiation date | Apr 22, 2024 |
| Quantity | 427,764 units |
| Location | Fort Worth, TX, United States |
Official product description
ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Why the product was recalled
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.
Distribution information
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Korea, Kuwait, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom. Product distributed as sterile stand-alone knives have been placed on HOLD. Product included within Alcon Custom Pak (surgical procedure pack) are continuing to be distributed as ceasing distribution would cause immediate market shortage and result in canceled surgeries.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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