Recall Z-1153-2014— Carl Zeiss Meditec AG

Name: FDA recall Z-1153-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-03

Class II · Terminated

Class II FDA medical device recall by Carl Zeiss Meditec AG, initiated 2014-02-03, terminated 2014-03-07. It names one FDA 510(k) clearance: K100253. 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.. Reason: Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S..

Recalling firm: Carl Zeiss Meditec AG
Classification: Class II
Status: Terminated
Initiated: 2014-02-03
Terminated: 2014-03-07
Firm location: Jena, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K100253 — VISUMAX LASER KERATOMECarl Zeiss Meditec, AG·cleared 2010-07-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.