Recall Z-0358-2016— Carl Zeiss Meditec AG

Name: FDA recall Z-0358-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-27

Class II · Terminated

Class II FDA medical device recall by Carl Zeiss Meditec AG, initiated 2015-10-27, terminated 2016-06-06. It names 3 FDA 510(k) clearances: K122418, K101182, K993357. Product: IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for 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.. Reason: IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data..

Recalling firm: Carl Zeiss Meditec AG
Classification: Class II
Status: Terminated
Initiated: 2015-10-27
Terminated: 2016-06-06
Firm location: Jena, Germany

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

IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for 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.

Reason for recall

IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.

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