Class 2 Device Recall VisuMax Laser Keratome

• Date Initiated by Firm: February 03, 2014
• Date Posted: March 07, 2014
• Recall Status: Terminated on March 07, 2014
• Recall Number: Z-1153-2014
• Recall Event ID: 67440
• 510(K)Number: K100253
• Product Classification: Laser, ophthalmic - Product Code HQF
• 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.
• Code Information: P/N 1462-333, Size M, Lot # M130010
• Recalling Firm/ Manufacturer: Carl Zeiss Meditec AG; Carl Zeiss Promenade 10; Jena Germany
• For Additional Information Contact: Judy A. Brimacombe, M.A.; 925-557-4616
• Manufacturer Reason for Recall: Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.
• FDA Determined Cause: Mixed-up of materials/components
• Action: The firm, Zeiss, sent an "Important Field Safety Advisory Note" letter dated February 3, 2014 to its customer. Letter indicates that a phone call preceded the letter on January 23, 2014. The letter also describes the product, problem and actions to be taken. The customers were instructed to quarantine all treatment packs size "M", batch number M 130010; return the material to Carl Zeiss Meditec, Inc., 5160 Hacienda Dr, Dublin, CA 94568 and Zeiss will issue a credit for all material received, upon receipt of the returned materia, and to complete and return the Conformation Form with the envelop provided. If you have any questions regarding this field corrective action, please call 925-557-4832 or email at paul.shahan@zeiss.com.
• Quantity in Commerce: 1 package containing 10 individual treatment packs
• Distribution: US Distribution: NV only.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HQF