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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

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.
Recall Number Z-1153-2014
Classification Class II
Code Info P/N 1462-333, Size M, Lot # M130010
Product Distributed Qty 1 package containing 10 individual treatment packs
Reason For Recall Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.

Event Detail

Event Id 67440
Product Type Devices
Status Terminated
Recalling Firm Carl Zeiss Meditec AG
City Jena
Country DE
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-03
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Distribution: NV only.