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FDA (Device enforcement)Recalled 2024-04-22class ii

Alcon Research LLC: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

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.

Details from the source

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. Distribution: 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 Afr Quantity: 4,930 units Lot/code info: Model/Catalog Number: 8065771541; UDI/DI: 00380657715411; Lot/Batch: 168NME, 168NND, 16AV17;

UPC codes

00380657715411

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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