FDAFDA · Food and drugs·Recall number Z-1153-2014
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.
Published March 19, 2014 · Recall initiated: February 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carl Zeiss Meditec AG
- Distributor
- US Distribution: NV only.
- Lot
- P/N 1462-333, Size M, Lot # M130010
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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