FDA-Device2014-03-19Class II
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
Carl Zeiss Meditec AG
Hazard
Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.
Sold states
US Distribution: NV only.
Affected count
1 package containing 10 individual treatment packs
Manufactured in
Carl Zeiss Promenade 10, N/A, Jena, N/A, Germany
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1153-2014Don't want to check this manually?
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