PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: March 19, 2014 Initiated: February 3, 2014 #Z-1153-2014

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Carl Zeiss Meditec AG
Units Affected
1 package containing 10 individual treatment packs
Distribution
US Distribution: NV only.
Location
Jena, N/A

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Carl Zeiss Meditec AG. Units affected: 1 package containing 10 individual treatment packs.
Why was this product recalled? ▼
Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 19, 2014. Severity: Moderate. Recall number: Z-1153-2014.

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