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Use caution Medical device recall · FDA · Published August 6, 2020

Carl Zeiss Meditec VISUREF150 Eye Diagnostic Device Recall: Electrical Shock Risk

Carl Zeiss Meditec recalls VISUREF150 eye diagnostic devices with serial numbers pending due to faulty DC/DC converter causing electrical shock risk. Affected units may have increased current leakage.

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

🇺🇸 FDA recall #Z-0614-2021Medical deviceCarl Zeiss Meditec ›
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Contact the company

Recalling firmCarl Zeiss Meditec AGCarl-Zeiss-Promenade 10 · Jena, Germany
✎ GovInfoNow plain-language explainer

Carl Zeiss Meditec is recalling VISUREF150 eye diagnostic devices that may have a faulty DC/DC converter. This could cause electrical shocks to users due to increased current leakage. Affected devices have pending serial numbers. Read more at govinfonow.com/recall/64517-carl-zeiss-meditec-visuref150-eye-diagnostic-device-recall-electrical-shock.

Source Summary by GovInfoNow · govinfonow.com/recall/64517-carl-zeiss-meditec-visuref150-eye-diagnostic-device-recall-electrical-shock · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0614-2021

Cite this page

“Carl Zeiss Meditec VISUREF150 Eye Diagnostic Device Recall: Electrical Shock Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64517-carl-zeiss-meditec-visuref150-eye-diagnostic-device-recall-electrical-shock. Based on FDA recall #Z-0614-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0614-2021%22&limit=1).

The FDA announced on August 6, 2020, that Carl Zeiss Meditec AG is recalling its VISUREF150 diagnostic instrument due to an electrical shock hazard. The recall involves 132 units distributed worldwide.

How to tell if you have it

  • Brand: Carl Zeiss Meditec
  • Product: VISUREF150
  • Catalog Number: 000000-2227-967
  • Serial Numbers: Pending

The hazard

The recall is due to an incorrect DC/DC converter being assembled onto the communication board, which may result in insufficient safety functions and increased current leakage. This defect potentially causes electrical shocks to the user.

Context

GovInfoNow's records show Carl Zeiss Meditec AG has had five other recalls since August 30, 2017. Recent brand recalls include a June 1, 2026, recall of the Zeiss Intrabeam Spherical Applicator for manufacturing defects and a March 16, 2022, recall of the ZEISS miLOOP Lens Fragmentation Device due to high friction risk. Other recent recalls of similar products include a December 15, 2025, recall of the Philips Allura Xper FD10C Medical System for electrical short-circuit risks and an April 20, 2026, recall of the GE Medical Systems Allia IGS 3 Pulse X-Ray System for electrical shock risk.

How to tell if you have this one

Check for the VISUREF150 model with catalog number 000000-2227-967. Serial numbers for affected units are pending and not yet assigned.

  • Brand
    Carl Zeiss Meditec
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, MI, MN, NC, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TX, UT, VA, WA and WY. The countries of Argentina, Austria, Australia, Belgium, Bolivia, Canada, Colombia, Croatia, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Latvia, Luxembourg, Malaysia, Maldives, Netherlands, Portugal, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.
Recall numberProduct, codes & lotsQuantity
Z-0613-2021Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displaying measurement values for sphere, cylinder and prism.; Model: VISUREF 150 Catalog Number: 000000-2227-967 Serial Numbers: Pending603 units
Z-0614-2021Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and keratometric characteristics of the human eye. The results are used to assist the process of prescribing optical aids such as eyeglasses and contact lenses.; Model: VISUREF 150 Catalog Number: 000000-2227-967 Serial Numbers: Pending132 units
Based on the official FDA remedy

What to do — step by step

  1. Check Device Serial Number

    Look for pending serial numbers on the device to confirm if it is affected by this recall.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 34 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: 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: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, MI, MN, NC, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TX, UT, VA, WA and WY. The…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Washington, Wyoming.

Recall timeline

FDA terminated this recall 4.4 years after the firm started it.

1. Firm started the recall: Aug 6, 202012. FDA classified it Class II: Dec 16, 202023. Published in FDA’s Enforcement Report: Dec 23, 202034. FDA terminated the recall: Dec 13, 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.

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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-0614-2021 (August 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0614-2021 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