Z-0680-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2019
- Initiation Date
- December 6, 2018
- Termination Date
- February 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
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