Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-1...

FDA Device Recall #Z-0108-2019 — Class II — June 25, 2018

Recall Summary

Recall Number Z-0108-2019
Classification Class II — Moderate risk
Date Initiated June 25, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Carl Zeiss Meditec AG
Location Jena, N/A
Product Type Devices
Quantity 1

Product Description

Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01

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.

Distribution Pattern

US: CA (Mountain View and San Jose) A single system. No distributed OUS.

Lot / Code Information

Model: 700 Catalog Number: 000000-1932-169 Serial Number: 1185393 UDI: 04049471092080

Other Recalls from Carl Zeiss Meditec AG

Recall # Classification Product Date
Z-1007-2022 Class II ZEISS miLOOP Lens Fragmentation Device REF 3030... Mar 16, 2022
Z-1133-2021 Class II IOLMaster 700 Dec 7, 2020
Z-0614-2021 Class II Carl Zeiss Meditec AG VISUREF150 REF 2227-967 -... Aug 6, 2020
Z-0613-2021 Class II Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038... Aug 6, 2020
Z-0001-2018 Class II Carl Zeiss INTRABEAM PRS 500, product #304534-0... Aug 30, 2017

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.