Reported Dec 25, 2019 · Terminated
VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the…
Carl Zeiss Meditec, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carl Zeiss Meditec, Inc. · 5160 Hacienda Dr · Dublin, CA · 94568-7562
Is this the product you have?
- 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 UsageThe 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
- Lot codes and dates
- Serial Numbers
71 of 71 codes
9881239881321008162100817310214461080079108946210894631105752110576511057661105773111590511159201115926112447511244761124478112448011244831136403114378411437951154532115453411560461156048115605311560591157773115942311594301161751116175311617561161763116176411617651164588116554111655451165548116555011655521165553116555411655551165562116556311655651168236116823911682431168244116824511682461168254117108211738261173832
- Serial Numbers
- Amount recalled
- 66 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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