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Lower risk Medical device recall · FDA · Published June 9, 2020

Bausch & Lomb enVista Intraocular Lens Recall: Misaligned Toric Axis Marks

Bausch & Lomb recalls enVista one-piece hydrophobic acrylic toric intraocular lenses with misaligned toric axis marks that could affect surgical outcomes after cataract removal.

🇺🇸 FDA recall #Z-2552-2020Medical 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 enVista one-piece hydrophobic acrylic toric intraocular lenses due to misaligned toric axis marks on implanted lenses. This could lead to improper alignment during cataract surgery, potentially affecting visual correction results. Read more at govinfonow.com/recall/65015-bausch-lomb-envista-intraocular-lens-recall-misaligned-toric-axis-marks.

Source Summary by GovInfoNow · govinfonow.com/recall/65015-bausch-lomb-envista-intraocular-lens-recall-misaligned-toric-axis-marks · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2552-2020

Cite this page

“Bausch & Lomb enVista Intraocular Lens Recall: Misaligned Toric Axis Marks.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65015-bausch-lomb-envista-intraocular-lens-recall-misaligned-toric-axis-marks. Based on FDA recall #Z-2552-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2552-2020%22&limit=1).

Bausch & Lomb Surgical, Inc. recalled enVista one-piece hydrophobic acrylic toric intraocular lenses on June 9, 2020, according to the FDA. The hazard is misaligned toric axis marks on implanted lenses.

How to tell if you have it

  • enVista one-piece hydrophobic acrylic toric intraocular lens
  • Model number: MX60ET
  • Catalog number: MXUET
  • Lot Number 3043212
  • Serial Numbers: 3043212002, 3043212005, 3043212006, 3043212007, 3043212008
  • UPC: 10757770555199

The hazard

The toric axis marks were misaligned from the expected position in relation to the haptics on an implanted lens.

Context

GovInfoNow's records show Bausch & Lomb Surgical, Inc. has 4 other recalls on record since 2018-11-05. Other recent recalls of similar products include Bausch & Lomb Akreos Intraocular Lenses Recall (2025-06-06) and Bausch & Lomb enVista Envy IOL and Toric IOL Recall (2025-03-27).

How to tell if you have this one

Check if your lens has the lot number 3043212 and serial numbers 3043212002 through 3043212008. These lenses were used for cataract surgery in adults to correct vision.

  • Brand
    Bausch & Lomb
  • Product
    enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Lens Details

    Verify your lens has the lot number 3043212 and serial numbers 3043212002 to 3043212008.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 5 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: named in the noticeCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “U.S. Nationwide distribution including in the states of IN, SC, CT, NV, and NC.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Connecticut, Indiana, Nevada, North Carolina, South Carolina.

Recall timeline

FDA terminated this recall 8 months after the firm started it.

1. Firm started the recall: Jun 9, 202012. FDA classified it Class II: Jul 10, 202023. Published in FDA’s Enforcement Report: Jul 22, 202034. FDA terminated the recall: Feb 11, 2021420202021
  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 there a risk of serious injury from this lens?

The recall addresses potential surgical misalignment, not a risk of injury during normal use. The hazard is specific to the surgical procedure.

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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-2552-2020 (June 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2552-2020 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