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 / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

Recall details

Manufacturer

Alcon Research LLC

Distributor

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 Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

Lot

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, 16852-06, 16938-06, 16988-10, 16999-16, 17017-09, 17018-06, 17033-04, 17056-06, 17059-12, 17064-07, 17142-05, 17190-06, 17201-18, 17207-18, 17212-06, 17254-04, 17259-12, 17268-03, 17269-05, 17271-04, 17294-09, 17306-04, 17333-08, 17382-11, 17416-11, 17437-09, 17464-04, 17484-04, 17533-04, 17570-05, 17600-08, 17600-10, 17617-05, 17633-09, 17634-08, 17692-05, 17696-08, 17696-09, 1770-57, 17718-06, 17736-02, 17752-08, 17794-08, 17795-06, 17833-07, 17850-03, 17884-07, 17960-12, 17973-07, 17992-08, 17993-09, 17994-08, 17996-06, 17996-09, 17998-08, 17999-09, 18000-06, 18001-09, 18005-05, 18011-08, 18012-08, 18012-09, 18014-07, 18015-07, 18018-06, 18032-09, 18049-09, 18050-10, 18072-07, 18082-06, 18124-02, 18198-04, 18215-06, 18220-05, 18232-02, 18247-05, 18251-13, 18253-13, 18253-14, 18292-05, 18341-12, 18369-03, 18382-04, 18382-06, 18400-06, 18404-05, 18406-03, 18422-02, 18483-04, 18484-04, 18512-01, 18536-06, 18545-06, 18552-04, 18613-03, 18647-06, 18648-11, 18648-12, 18661-11, 18661-13, 18664-03, 18701-05, 18712-07, 18718-04, 18719-04, 18803-03, 18812-03, 18812-04, 18814-01, 18830-05, 18855-03, 18886-04, 18886-05, 18888-04, 18941-04, 18942-03, 18964-04, 18965-06, 18971-01, 18984-02, 18986-03, 19016-04, 19022-03, 19033-03, 19042-02, 19042-03, 19042-04, 19059-02, 19061-02, 19079-02, 19105-03, 19105-04, 19126-06, 19131-05, 19185-06, 19186-06, 19186-07, 19204-02, 19205-04, 19207-03, 19209-01, 19230-04, 19263-02, 19263-03, 19265-05, 19268-02, 19274-06, 19289-02, 19290-02, 19291-02, 19292-03, 19293-02, 19325-04, 19331-04, 19342-02, 19373-04, 19380-02, 19411-01, 19438-02, 19459-06, 19466-01, 19533-02, 19534-02, 19554-02, 19578-04, 19582-02, 19588-01, 19594-01, 19615-01, 19630-02, 19630-06, 19631-02, 19631-05, 19632-02, 19632-06, 19633-02, 19633-05, 19633-07, 19634-02, 19634-05, 19639-02, 19647-02, 19647-04, 19673-03, 19727-01, 19729-05, 19730-01, 19763-01, 19779-04, 19821-02, 19848-01, 19857-03, 19918-01, 2142-77, 2510-73, 2693-66, 2699-65, 2721-69, 2735-59, 3012-66, 3115-23, 3122-25, 3128-45, 3607-75, 3843-23, 4023-28, 4342-28, 4399-17, 4566-34, 4647-61, 4733-21, 4953-20, 5034-32, 5264-21, 5479-62, 5518-43, 5624-22, 5660-63, 5663-18, 5675-76, 5713-27, 5884-22, 5947-61, 6003-13, 6038-60, 6544-16, 6648-21, 6909-66, 6914-67, 6977-24, 8128-64, 8264-74, 8264-75, 8266-68, 8300-64, 8318-24, 8356-13, 8563-66, 8567-75, 8851-33, 8924-69, 9090-66, 9097-39, 9138-17, 9319-33, 9354-65, 9391-26, 9441-65, 9458-70, 9677-33, 9748-68, 9894-71, 9966-35, 9966-36, AS0206-74, AS0425-80, AS

Risk classification

Class II

Area (FDA)

device

Country

United States