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Lower risk Medical device recall · FDA · Published November 7, 2020

Bausch & Lomb MX60ET Toric Lens Recall: Missing Toric Axis Marks

Bausch & Lomb recalls MX60ET toric contact lenses due to possible missing toric axis marks. Affected lenses may not fit properly during eye surgery.

🇺🇸 FDA recall #Z-0519-2021Medical deviceBausch & Lomb ›
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Contact the company

Recalling firmBausch & Lomb Surgical, Inc.21 N Park Place Blvd · Clearwater, FL 33759-3917
✎ GovInfoNow plain-language explainer

Bausch & Lomb is recalling MX60ET toric contact lenses because some lenses may be missing toric axis marks. This could cause improper placement during eye surgery, potentially leading to vision issues. Read more at govinfonow.com/recall/63972-bausch-lomb-mx60et-toric-lens-recall-missing-toric-axis-marks.

Source Summary by GovInfoNow · govinfonow.com/recall/63972-bausch-lomb-mx60et-toric-lens-recall-missing-toric-axis-marks · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0519-2021

Cite this page

“Bausch & Lomb MX60ET Toric Lens Recall: Missing Toric Axis Marks.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63972-bausch-lomb-mx60et-toric-lens-recall-missing-toric-axis-marks. Based on FDA recall #Z-0519-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0519-2021%22&limit=1).

Bausch & Lomb Surgical, Inc. recalled the MX60ET enVista One-Piece Hydrophobic Acrylic Toric intraocular lens because it may be missing toric axis marks, according to the FDA on Nov. 7, 2020.

How to tell if you have it

  • Brand: Bausch & Lomb
  • Product: MX60ET (enhanced enVista Toric) enVista One-Piece Hydrophobic Acrylic Toric Model MX60ET
  • Lot number: 3043816
  • Serial numbers: 3043816001, 3043816002, 3043816003, 3043816004, 3043816005, 3043816006, 3043816007, 3043816008, 3043816009, 3043816010, 3043816011, 3043816012, 3043816013, 3043816014, 3043816015, 3043816016, 3043816017, 3043816018, 3043816019, 3043816020, 3043816023, 3043816024, 3043816025, 3043816026, 3043816027, 3043816028, 3043816029, 3043816030, 3043816031
  • Units affected: 31 devices

The hazard

The product may be missing toric axis marks. The lens is intended for placement in the capsular bag.

Context

GovInfoNow's records show Bausch & Lomb Surgical, Inc. has 4 other recalls on record since Nov. 5, 2018. Other recent recalls of similar products include Bausch & Lomb Akreos Intraocular Lenses Recall (June 6, 2025), Bausch & Lomb enVista Envy IOL and Toric IOL Recall (March 27, 2025), and Bausch & Lomb enVista Intraocular Lens Recall (June 9, 2020). Other recent recalls of similar products include TECNIS Eyhance IOL with Simplicity Delivery System Recall (Feb. 19, 2026), Olympus HX-400U-30 Ligating Device Recall (Oct. 30, 2025), and Zeiss Intrabeam Spherical Applicator 1.5 cm Recall (June 1, 2026).

How to tell if you have this one

Check for lot number 3043816 and serial numbers from 3043816001 to 3043816031. These lenses were sold in specific batches for cataract surgery procedures.

  • Brand
    Bausch & Lomb
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Lens Details

    Verify your lens has lot number 3043816 and serial numbers between 3043816001 and 3043816031.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 11 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution including in the states of FL, CA, MO, MN, TN, TX, MI, WA, UT, NH, and OH.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Michigan, Minnesota, Missouri, New Hampshire, Ohio, Tennessee, Texas, Utah, Washington.

Recall timeline

FDA terminated this recall 3.7 years after the firm started it.

1. Firm started the recall: Nov 7, 202012. FDA classified it Class II: Dec 2, 202023. Published in FDA’s Enforcement Report: Dec 9, 202034. FDA terminated the recall: Jul 11, 2024420202024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

Is this a safety hazard?

This is a low-risk issue as the lenses may not fit properly during surgery, but it does not cause immediate injury or death.

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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-0519-2021 (November 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0519-2021 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