Reported Jun 24, 2015 · Terminated

BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584676 Ophthalmic…

Beaver-Visitec International Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Beaver-Visitec International Inc. · 411 Waverley Oaks Rd Ste 229 · Waltham, MA · 02452-8422

Is this the product you have?

  • BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon
  • Light Glove Part Number584676 Ophthalmic surgical kits
Lot codes and dates
  • Lot Numbers3068113 3078510 3086351 3089841 3096796
Amount recalled
268 kits

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

Why it was recalled

Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 28, 2021 · Data as of Sep 19, 5:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.