Alcon Research, LLC: Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-2

Hazard

Sterility; Steril surgical procedure packs contain incomplete seals.

Details from the source

Reason for recall: Sterility; Steril surgical procedure packs contain incomplete seals. Distribution: US: AL, AR, CA, IA, ID, IN, KY, MN, NC, ND, NJ, OH, PA, TX, OUS: None Quantity: 1035 packs Lot/code info: Lot #-Pack #-Expiry Date - UDI: 158JNA 17533-04 9/30/2024 00380655132814; 158L18 18704-03 12/31/2024 00380651672833; 158JNN 18382-03 10/31/2024 00380655117132; 158L27 8685-21 09/30/2024 00380655142486; 158L24 19451-02 09/30/2024 00380655143995; 158L44 19136-03 12/31/2024 00380655129975; 158HU3 18401-03 04/30/2024 00380651651487; 158MH8 16032-05 12/31/2024 00380653369250; 158L5X 17570-05 10/31/2024 00380655129227; 158NEX 19002-02 10/31/2024 00380655120231; 158MJ3 10560-14 12/31/2024 00380655136317; 158NE8 16877-11 12/31/2024 00380655116579; 158NDK 19061-02 08/31/2024 00380655118504; 158NEM 18911-02 04/30/2024 00380651691940; 158PCP 17469-02 08/31/2024 00380653377156; 158PCD 18917-01 09/30/2024 00380651677333; 158P8K 17115-06 07/31/2024 00380651698079; 158NDC 17780-04 12/31/2024 00380651682719; 158N9Y 2452-58 12/31/2024 00380653403589; 158MFC 19096-01 10/31/2024 00380651696235; 158MHL 18023-04 10/31/2024 00380651661189; 158P7W 17039-13 08/31/2024 00380651701229; 158P97 5300-61 10/31/2024 00380651672659;

UPC codes

00380655132814, 00380651672833, 00380655117132, 00380655142486, 00380655143995, 00380655129975, 00380651651487, 00380653369250, 00380655129227, 00380655120231, 00380655136317, 00380655116579, 00380655118504, 00380651691940, 00380653377156, 00380651677333, 00380651698079, 00380651682719, 00380653403589, 00380651696235, 00380651661189, 00380651701229, 00380651672659

Source

Official record: FDA (Device enforcement) ↗

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