OTLClass III

Femtosecond Laser System For Refractive Correction

Unknown

Ophthalmic femtosecond laser intended to provide refractive vision correction by modification of the shape of the cornea

MDR events74All time

Recalls1All time

Registered firms3Currently listed

510(k) clearances0All time

Recent MDR events

74 adverse event reports on file

Event type breakdown

Injury69

Malfunction5

Most-reported manufacturers

Carl Zeiss Meditec Ag (jena)63 Unk6 Unspecified2 Carl Zeiss Meditec Ag1 Carl Zeiss Meditec, Inc.1 Nidek Co., Ltd.1 Unknown1

Recalls

1 recall events for this product code

Carl Zeiss Meditec, Inc.
TerminatedUnknown
VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractiv
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.
Z-0680-2020 · View FDA record ↗

Registered firms

3 firms currently registered for this product code

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for this product code.

PMA approvals

1 premarket approvals for this product code

Carl Zeiss Meditec, Inc.Sep 13, 2016
P150040 · VISUMAX FEMTOSECOND LASER