Class 2 Device Recall Carl Ziess Meditec AG IOLMaster 700

• Date Initiated by Firm: June 25, 2018
• Create Date: October 15, 2018
• Recall Status: Terminated on January 15, 2021
• Recall Number: Z-0108-2019
• Recall Event ID: 81000
• 510(K)Number: K170171
• Product Classification: Biomicroscope, slit-lamp, ac-powered - Product Code HJO
• Product: Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
• Code Information: Model: 700 Catalog Number: 000000-1932-169 Serial Number: 1185393 UDI: 04049471092080
• Recalling Firm/ Manufacturer: Carl Zeiss Meditec AG; Carl-Zeiss-Promenade 10; Jena Germany
• Manufacturer Reason for Recall: Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the anterior and posterior segments of the eye.
• FDA Determined Cause: Employee error
• Action: On 08/06/2018 the firm sent a Field Safety Corrective Action letter to customers via FedEx Priority Overnight service informing them that based on routine post market surveillance activities, we have information that this specific IOLMaster 700 device is incorrectly calibrated. The calibration value for axial length measurement was not entered correctly in the device settings during the manufacturing process. The transmission discrepancy leads to an error during the axial length measurement of approx. 0.25mm. A deviation in the axial length of this magnitude results in an error of Single unit. approx. 0.8 Diopter with regard to the intraocular lens. This in turn results in a refractive error of about 0.5 Diopter. The local firm's service organization will remove this device from the field. The device manufacturer will recalibrate the device to ensure it meets specifications. Hazard involved: The likelihood of a faulty entered calibration value for axial length measurement in the production process of IOLMaster 700 is considered rare. The probability of injury, i.e. reduced visual acuity due to the implantation of a wrong IOL power, is very likely for the affected device, because the axial length of the eye cannot be measured correctly. The device failure may only be recognized through post-surgical examination. Affected product: Quantity: 1 Product Name: IOLMaster 700 Product Number: 000000-1932-169 Device Serial Number: 1185393 Manufacturing Date: 2017-09-18 Actions to be taken: 1. Discontinue use of the ZEISS IOLMaster 700 device (Serial Number 1185393). Physicians are asked to review refractive results during usage of this device and to inform the firm about any hyperopic refractive surprises noticed. Any measurement and calculation data from this device should not be taken into consideration for further treatments. 2. Complete and return the attached Medical Device Recall Return Response Form to USFCA.meditec.us@zeiss.com no later than Jun
• Quantity in Commerce: 1
• Distribution: US: CA (Mountain View and San Jose) A single system. No distributed OUS.
• 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 = HJO