Alcon Research LLC: Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / conv

Hazard

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.

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 Comeal/Scleral V-Lance Ophthalmic knives. Distribution: 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 Quantity: 384,851 units Lot/code info: UDI-DIs: H5301ALCON1CPAK10 and H5302ALCON2CPAK20; Model Catalog numbers: 0210-71, 0515-65, 0613-84, 0775-69, 0835-60, 0852-75, 0884-77, 0900-28, 0972-31, 0995-82, 10027-12, 10066-19, 10068-19, 10214-20, 10214-21, 10275-17, 10308-11, 10342-17, 10477-21, 10568-13, 10604-09, 10731-20, 10772-35, 10782-30, 10825-17, 10931-13, 11066-08, 11220-25, 11367-23, 11413-14, 11414-07, 11426-24, 11497-12, 11732-16, 1192-67, 11952-15, 11958-08, 11994-15, 12005-09, 12262-06, 12329-16, 12346-08, 12359-14, 12364-13, 12376-03, 12382-10, 1239-67, 12417-11, 1249-62, 12498-07, 12518-11, 12532-05, 12698-09, 12699-12, 12918-12, 12918-13, 12942-18, 1303-69, 13204-19, 13214-21, 13335-11, 13569-13, 13578-17, 13592-15, 13614-16, 13644-08, 13657-10, 13732-19, 13870-09, 13894-16, 13944-12, 13955-09, 13982-13, 14129-09, 14174-15, 14226-12, 14302-07, 14362-18, 14363-14, 14385-05, 14387-05, 14429-09, 14442-16, 14477-12, 14611-15, 14688-15, 14719-09, 14853-13, 14864-11, 15061-09, 15133-16, 15190-16, 15194-09, 15220-10, 15260-18, 15268-15, 15269-07, 15302-07, 15326-13, 15332-07, 15369-05, 15405-12, 15433-12, 15435-13, 15436-09, 15437-06, 15438-09, 15469-03, 15542-11, 15632-08, 15665-10, 15679-08, 15797-19, 15840-04, 15878-07, 15966-05, 16023-14, 16077-09, 16123-10, 16204-13, 16374-12, 16385-17, 16462-08, 16469-09, 1647-76, 16493-11, 16537-07, 16546-04, 16561-06, 16573-07, 16595-10, 16611-10, 16613-14, 16667-10, 16674-07, 16703-05, 16710-06, 16735-10, 16748-08, 16773-15, 16773-16, 16779-12, 16793-16, 16799-08, 16

Source

Official record: FDA (Device enforcement) ↗

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