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Use caution Medical device recall · FDA · Published March 16, 2022

ZEISS miLOOP Lens Fragmentation Device Recall: High Friction Risk During Cataract Surgery

ZEISS miLOOP Lens Fragmentation Device (model 303071-9090-000) used in cataract surgery may stick due to high friction. Affected units sold in 2011-2023; recall issued for safety.

🇺🇸 FDA recall #Z-1007-2022Medical deviceCarl Zeiss Meditec ›
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Recalling firmCarl Zeiss Meditec AGRudolf-Eber-Str. 11 · Oberkochen, Germany
✎ GovInfoNow plain-language explainer

What happened, in plain English

Carl Zeiss Meditec recalls a specific lens fragmentation device used in cataract surgery because high friction can cause it to stick or not move as intended. This could lead to surgical complications if the device fails during use. Read more at govinfonow.com/recall/60926-zeiss-miloop-lens-fragmentation-device-recall-high-friction-risk-during.

Source Summary by GovInfoNow · govinfonow.com/recall/60926-zeiss-miloop-lens-fragmentation-device-recall-high-friction-risk-during · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1007-2022

Cite this page

“ZEISS miLOOP Lens Fragmentation Device Recall: High Friction Risk During Cataract Surgery.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/60926-zeiss-miloop-lens-fragmentation-device-recall-high-friction-risk-during. Based on FDA recall #Z-1007-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1007-2022%22&limit=1).

Why it’s dangerous

The device's slider has high friction that can cause it to stick or not move properly during surgery. If the device fails to function correctly, it could lead to surgical complications or delays.

Who’s affected

Surgical teams using the ZEISS miLOOP device for cataract surgery are most at risk. Patients undergoing this procedure with the recalled model may be affected.

How to tell if you have this one

Check for the model number 303071-9090-000 on the device. Units sold between 2011 and 2023 with lot number FG21082410 are affected.

  • Brand
    Carl Zeiss Meditec
  • Product
    ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Model

    Look for the model number 303071-9090-000 on the device or its packaging.

  2. Contact Manufacturer

    Reach out to Carl Zeiss Meditec for guidance on next steps if you have the recalled model.

Where it went and when

Where it was distributed

Distributed in 31 states and Puerto Rico.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: yesMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: yesIAIndiana: not listedINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “U.S.: AL, AR, AZ, CA, CT, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OR, PA, Puerto Rico, SC, TN, TX. UT, VA, WA, and WV O.U.S.: Not provided” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Connecticut, Florida, Georgia, Illinois, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia.

Recall timeline

FDA published this recall 49 days after the firm started it.

1. Firm started the recall: Mar 16, 202212. FDA classified it Class II: Apr 26, 202223. Published in FDA’s Enforcement Report: May 4, 202232022
  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-1007-2022 (March 16, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1007-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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