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Carl Zeiss Meditec AG recalls Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany.
Recalled March 19, 2014 · FDA recall Z-1153-2014 · Carl Zeiss Meditec AG
Hazard
Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S. · FDA Class II
Units
1 package containing 10 individual treatment packs
Sold at
US Distribution: NV only.
Description
Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.
Product
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 following: In 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.
Manufacturer(s)
Carl Zeiss Meditec AG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →