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Lower risk Medical device recall · FDA · Published March 15, 2024

Alcon Custom Paks Surgical Procedure Packs with Oasis 27Ga Chang Hydrodissection Cannulas

Alcon recalls various Custom Paks Surgical Procedure Packs containing Oasis 27Ga Chang Hydrodissection Cannulas due to complaints of particulates, residue, occlusions, and bent tips. These packs are used by ophthalmic surgeons in eye surgeries.

🇺🇸 FDA recall #Z-1606-2024Medical deviceAlcon ›
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Recalling firmAlcon Research, LLC9965 Buffalo Speedway · Houston, TX 77054-1309
✎ GovInfoNow plain-language explainer

What happened, in plain English

Alcon is recalling various Custom Paks Surgical Procedure Packs that contain Oasis 27Ga Chang Hydrodissection Cannulas. These products have been reported to have particulates, residue, occlusions, and bent tips, which could pose risks during eye surgery. Read more at govinfonow.com/recall/55871-alcon-custom-paks-surgical-procedure-packs-with-oasis-27ga-chang.

Source Summary by GovInfoNow · govinfonow.com/recall/55871-alcon-custom-paks-surgical-procedure-packs-with-oasis-27ga-chang · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1606-2024

Cite this page

“Alcon Custom Paks Surgical Procedure Packs with Oasis 27Ga Chang Hydrodissection Cannulas.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55871-alcon-custom-paks-surgical-procedure-packs-with-oasis-27ga-chang. Based on FDA recall #Z-1606-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1606-2024%22&limit=1).

Why it’s dangerous

The cannulas in these packs have been reported to have particulates, residue, occlusions, and bent tips. These issues could potentially interfere with surgical procedures and cause complications during eye surgery.

Who’s affected

Ophthalmic surgeons who use these Custom Paks Surgical Procedure Packs for eye surgeries are likely affected. The risk is primarily for medical professionals handling the products.

How to tell if you have this one

Check for Custom Paks Surgical Procedure Packs with Oasis 27Ga Chang Hydrodissection Cannulas. The packs are identified by specific lot numbers and reference codes listed in the recall notice, such as 0515-66, 0752-74, 1119-82, etc.

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

What to do — step by step

  1. Check Product Details

    Look for the specific Custom Pak reference codes and lot numbers listed in the recall notice, such as 0515-66, 0752-74, 1119-82, etc.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 36 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - U.S. Nationwide including in the states of AK, AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alaska, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Montana, Nebraska, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 47 days after the firm started it.

1. Firm started the recall: Mar 15, 202412. FDA classified it Class II: Apr 22, 202423. Published in FDA’s Enforcement Report: May 1, 202432024
  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.

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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-1606-2024 (March 15, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1606-2024 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