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U.S. Department of Health and Human Services

Class 2 Device Recall VisuMax Laser Keratome

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  Class 2 Device Recall VisuMax Laser Keratome see related information
Date Initiated by Firm February 03, 2014
Date Posted March 07, 2014
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = CARL ZEISS MEDITEC AG
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