FDAFDA · Food and drugs·Recall number Z-1924-2024
ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Published June 5, 2024 · Recall initiated: April 22, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Alcon Research LLC
- Distributor
- 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.
- Lot
- Model/Catalog Number: 8065771540; UDI/DI: 00380657715404; Lot/Batch: 1668D7, 167PRA, 167PTK, 168NMF, 169KL4, 169KTP, 16ALPE, 16ALTU, 16AV18, 16DDPR, 16DDRU;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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