Recall Z-0333-2014— Carl Zeiss Meditec, Inc.

Name: FDA recall Z-0333-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-23

Class II · Terminated

Class II FDA medical device recall by Carl Zeiss Meditec, Inc., initiated 2013-10-23, terminated 2014-04-17. It names 3 FDA 510(k) clearances: K122418, K101182, K993357. Product: Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation. Reason: The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value..

Recalling firm: Carl Zeiss Meditec, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-23
Terminated: 2014-04-17
Firm location: Dublin, CA, United States

510(k) clearances named in this recall

3 on FDA's record

K122418 — IOLMASTER 500Carl Zeiss Meditec, AG·cleared 2013-04-12
K101182 — IOLMASTER 500Carl Zeiss Meditec, AG·cleared 2010-11-03
K993357 — IOLMASTERCarl Zeiss, Inc.·cleared 2000-03-20

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

Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

Reason for recall

The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value.

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