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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2648-2024

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

Publicado el 28 de agosto de 2024 · Inicio del retiro: 15 de julio de 2024

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Alcon Research LLC
Distribuidor
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
Lote
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
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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