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Lower risk Medical device recall · FDA · Published March 10, 2023

Alcon Custom Pak Surgical Procedure Packs: Sterility Risk from Incomplete Seals

Alcon recalls surgical procedure packs with incomplete sterilization seals that could lead to infections. Affected packs have specific lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1291-2023Medical deviceAlcon ›
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Contact the company

Recalling firmAlcon Research, LLC9965 Buffalo Speedway · Houston, TX 77054-1309
✎ GovInfoNow plain-language explainer

Alcon is recalling surgical procedure packs that may have incomplete sterilization seals, which could lead to infections if used. This affects specific packs sold to eye surgery centers and clinics. Read more at govinfonow.com/recall/58763-alcon-custom-pak-surgical-procedure-packs-sterility-risk-from-incomplete.

Source Summary by GovInfoNow · govinfonow.com/recall/58763-alcon-custom-pak-surgical-procedure-packs-sterility-risk-from-incomplete · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1291-2023

Cite this page

“Alcon Custom Pak Surgical Procedure Packs: Sterility Risk from Incomplete Seals.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58763-alcon-custom-pak-surgical-procedure-packs-sterility-risk-from-incomplete. Based on FDA recall #Z-1291-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1291-2023%22&limit=1).

The FDA announced on March 10, 2023, that Alcon Research LLC is recalling Alcon Custom Pak Surgical Procedure Packs due to sterility risks from incomplete seals. The agency issued recall number Z-1291-2023 for the voluntary Class II action affecting 1,035 units distributed in several U.S. states.

How to tell if you have it

  • Brand: Alcon
  • Product: Alcon Custom Pak Surgical Procedure Pack
  • Pak Numbers: 17533-04, 18704-03, 18382-03, 8685-21, 19451-02, 19136-03, 18401-03, 16032-05, 17570-05, 19002-02, 10560-14, 16877-11, 19061-02, 18911-02, 17469-02, 18917-01, 17115-06, 17780-04, 2452-58, 19096-01, 18023-04, 17039-13, 5300-61
  • Lot Codes: 158JNA, 158L18, 158JNN, 158L27, 158L24, 158L44, 158HU3, 158MH8, 158L5X, 158NEX, 158MJ3, 158NE8, 158NDK, 158NEM, 158PCP, 158PCD, 158P8K, 158NDC, 158N9Y, 158MFC, 158MHL, 158P7W, 158P97
  • UPCs: 00380655132814, 00380651672833, 00380655117132, 00380655142486, 00380655143995, 00380655129975, 00380651651487, 00380653369250, 00380655129227, 00380655120231, 00380655136317, 00380655116579, 00380655118504, 00380651691940, 00380653377156, 00380651677333, 00380651698079, 00380651682719, 00380653403589, 00380651696235, 00380651661189, 00380651701229, 00380651672659
  • Distribution: AL, AR, CA, IA, ID, IN, KY, MN, NC, ND, NJ, OH, PA, TX

The hazard

The recall addresses sterility risks because the steril surgical procedure packs contain incomplete seals. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Alcon Research LLC has 24 other recalls on record since July 25, 2018. Recent brand-specific actions include the April 21, 2026 GenTeal Tears Eye Gel recall for lack of sterility assurance and the Nov. 24, 2025 Custom Pak recall regarding incomplete seals affecting sterility. Other recent recalls of similar products include the Jan. 7, 2026 Medline Surgical Packs recalls for calibration issues impacting sterility and the Dec. 15, 2025 Intuitive Surgical da Vinci SP Access Port Kit recall for cracks risking sterility breach.

How to tell if you have this one

Check for pack numbers like 17533-04, 18704-03, or 18382-03 on the surgical packs. These packs were sold to specific eye surgery centers with expiration dates listed on the packaging.

  • Brand
    Alcon
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Pack Number

    Look for specific pack numbers such as 17533-04, 18704-03, or 18382-03 on the surgical procedure packs.

Where it went and when

Where it was distributed

Distributed in 14 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: yesIDMontana: not listedMTNorth Dakota: yesNDMinnesota: yesMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: yesKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: yesARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: yesALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “US: AL, AR, CA, IA, ID, IN, KY, MN, NC, ND, NJ, OH, PA, TX, OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arkansas, California, Idaho, Indiana, Iowa, Kentucky, Minnesota, New Jersey, North Carolina, North Dakota, Ohio, Pennsylvania, Texas.

Recall timeline

FDA published this recall 26 days after the firm started it.

1. Firm started the recall: Mar 10, 202312. FDA classified it Class II: Mar 28, 202323. Published in FDA’s Enforcement Report: Apr 5, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are these packs still safe to use?

The recall states that the packs may have incomplete sterilization seals, so they are not safe for use without checking the pack number and expiration date.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1291-2023 (March 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1291-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA