Reported Dec 9, 2020 · Terminated

MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is…

Bausch & Lomb Surgical, 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: Bausch & Lomb Surgical, Inc. · 21 N Park Place Blvd · Clearwater, FL · 33759-3917

Is this the product you have?

  • MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic
  • Toric Model MX60ET - Product UsageThe lens is intended for placement in the capsular bag
Lot codes and dates
  • Lot number3043816
  • 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
Amount recalled
31 devices

Where it was sold

Why it was recalled

Product may be missing toric axis marks.

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 Jul 11, 2024 · Data as of Sep 19, 5:36 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.