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BfArM publishes Beaver-Visitec field safety notice for Mini-Blade and Lamellar Blade devices

🇩🇪 BfArM field safety notices · Wed 04 Nov 2026

Germany's medicines and devices regulator has posted an urgent field safety notice from Beaver-Visitec International covering two ophthalmic surgical blade products, with details held in a manufacturer PDF.

The German Federal Institute for Drugs and Medical Devices (BfArM) has published an Urgent Field Safety Notice from Beaver-Visitec International, Inc. The notice covers the company's Mini-Blade and Lamellar Blade products and is dated 4 November 2026.

BfArM classes the products under ophthalmological technology, specifically equipment for ophthalmological therapeutics. The entry carries the reference number 50525/26.

The BfArM item does not describe the defect or risk behind the notice. It also does not list affected lots or set out what users are expected to do. It refers readers to the manufacturer's Advisory Notice, supplied as a 347 KB PDF download. BfArM flags that the file does not meet accessibility standards.

As general context, a field safety notice is the communication a manufacturer sends to customers when it takes a field safety corrective action on a medical device already on the market. Regulators such as BfArM publish these notices so that users and healthcare facilities can find them.

What it means for your team

  • Obtain and read the manufacturer's Advisory Notice, as the BfArM page contains no details on the issue, affected lots or required actions.
  • Hospitals, ophthalmic surgery units and distributors should check whether they hold Mini-Blade or Lamellar Blade stock from Beaver-Visitec.
  • Quality and vigilance teams should log reference 50525/26 and record the date and outcome of any stock check.

Official source: BfArM field safety notices ↗

Article written by VigiEye from the official source (BfArM field safety notices). AI-assisted; check the source before acting.

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