--- title: "Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533... — FDA record Z-1291-2023 | Is It on Recall" description: "Sterility; Steril surgical procedure packs contain incomplete seals." url: https://isitonrecall.com/recall/fda-device-z-1291-2023-alcon-custom-pak-surgical-procedure-pack-pak-number-pak-description-17533-04-dr-gross-lps-llc-18704/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT S... — FDA record Z-1291-2023 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Mar 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: 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 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 19136-03 OCCULOPLASTIC WILMINGTON EYE 18401-03 MCGRAW SIGHTPATH MEDICAL 16032-05 MIDDLE TENNESSEE PACK SIGHTPATH MEDICAL 17570-05 CATARACT CENTURION FORT MADISON COMM HOS 19002-02 CATARACT BAPTIST HEALTH SURGERY CENTER 10560-14 CATARACT - NORTH CENTRAL 1 SIGHTPATH MED 16877-11 DR DAVID B LEACH CLEARVIEW SURGERY CENTE 19061-02 HOSLER UNIVERSITY SURGI CENTER 18911-02 MASON CATARACT THE ASC AT UNITED MEDICAL 17469-02 GENERAL CUSTOM PACK SHARP MEMORIAL HOSPI 18917-01 CATARACT 2 SURGERY CENTER OF THE TEMECUL 17115-06 DR SCZEPANSKI NORTH DAKOTA EYE CLINIC 17780-04 OPHTHALMIC TEXAS PRECISION SURGERY CENTE 2452-58 CATARACT BOLSA OUTPATIENT SURG CTR 19096-01 OPHTHALMIC EAST ALABAMA AMB SURGERY CENT 18023-04 OPHTHALMIC BRAINARD SURGERY CENTER 17039-13 EYE-Q COMPLETE CAT PAK VISION CARE SURG 5300-61 CATARACT WOODLAND MEM HOSP - **Reason**: Sterility; Steril surgical procedure packs contain incomplete seals. - **Classification**: Class II - **Recalling firm**: Alcon Research, LLC - **Quantity**: 1035 packs - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1291-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1291-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 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; | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US: AL, AR, CA, IA, ID, IN, KY, MN, NC, ND, NJ, OH, PA, TX, OUS: None States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [California](https://isitonrecall.com/state/california/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Texas](https://isitonrecall.com/state/texas/) ## Dates in the source - **Report date**: Apr 5, 2023 - **Recall initiation date**: Mar 10, 2023 - **Center classification date**: Mar 28, 2023 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1291-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Alcon Research, LLC records](https://isitonrecall.com/brand/alcon-research-llc/)