VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conj...
FDA Device Recall #Z-0680-2020 — Class II — December 6, 2018
Recall Summary
| Recall Number | Z-0680-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 6, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Carl Zeiss Meditec, Inc. |
| Location | Dublin, CA |
| Product Type | Devices |
| Quantity | 66 units |
Product Description
VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision ophthalmic surgical laser designed for the creation of incisions in the cornea. The VisuMax Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia. This device is intended for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia >=-1.00 D to <=-8.00 D, with <=-0.50 D cylinder and MRSE <=-8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change of <=0.50 D MRSE.
Reason for Recall
VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a software issue. In case of a suction loss during treatment the software allows the user to choose the option immediate restart or restart treatment. Suction loss can occur in phase 1 through phase 5. The software defect refers to Phase 2 (between 10% and 100% of lower lenticule cut) only. The software offers a flap cut, but due to the software issue it performs a cap cut instead of a flap cut if the user proceeds.
Distribution Pattern
US nationwide distribution.
Lot / Code Information
Serial Numbers: 988123 988132 1008162 1008173 1021446 1080079 1089462 1089463 1105752 1105765 1105766 1105773 1115905 1115920 1115926 1124475 1124476 1124478 1124480 1124483 1136403 1143784 1143795 1154532 1154534 1156046 1156048 1156053 1156059 1157773 1159423 1159430 1161751 1161753 1161756 1161763 1161764 1161765 1164588 1165541 1165545 1165548 1165550 1165552 1165553 1165554 1165555 1165562 1165563 1165565 1168236 1168239 1168243 1168244 1168245 1168246 1168254 1171082 1173826 1173832 1173838 1182193 1182194 1182195 1182196 1182198 1186711 1186713 1192911 1192914 1196018
Other Recalls from Carl Zeiss Meditec, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0723-2022 | Class II | CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 A... | Jan 14, 2022 |
| Z-2227-2021 | Class II | Chassis Label - "CIRRUS HD-OCT Rx-Only" Prod... | Jul 8, 2021 |
| Z-0770-2020 | Class II | The PLEX Elite 9000, a Swept-Source OCT [SS-OCT... | Oct 16, 2018 |
| Z-0334-2014 | Class II | Zeiss brand IOLMaster 500, Model 500, Biomicros... | Oct 23, 2013 |
| Z-0333-2014 | Class II | Zeiss brand IOLMaster, Version 1-5, Biomicrosco... | Oct 23, 2013 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
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.