Reported Mar 19, 2014 · Terminated

Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The…

Carl Zeiss Meditec AG

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: Carl Zeiss Meditec AG · Carl Zeiss Promenade 10 · Jena, N/A · N/A

Is this the product you have?

  • Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser
  • Keratome is indicated for the followingIn the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting
Lot codes and dates
    • P/N 1462-333
    • Size M
    • Lot # M130010
Amount recalled
1 package containing 10 individual treatment packs

Where it was sold

Why it was recalled

Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.

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 Mar 7, 2014 · Data as of Sep 19, 5:33 PM UTC

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