Home › Device types › LZS
Excimer Laser System
FDA product code LZS · Class 3 · Unknown
26
Registered devices
13,736
Adverse events
29
Recalls
0
510(k) clearances
Devices with this code
Final Fit™ — NIDEK CO.,LTD.WAVELIGHT ALLEGRO TOPOLYZER — Alcon Laboratories, Inc.WAVELIGHT REFRACTIVE SUITE — Alcon Laboratories, Inc.WAVELIGHT REFRACTIVE SUITE — Alcon Laboratories, Inc.Final Fit — NIDEK CO.,LTD.WAVESCAN OFFLINE PROGRAMMING MODULE — JOHNSON & JOHNSON SURGICAL VISION, INC.IDESIGN RS — JOHNSON & JOHNSON SURGICAL VISION, INC.WAVELIGHT REFRACTIVE SUITE — Alcon Laboratories, Inc.WAVELIGHT REFRACTIVE SUITE — Alcon Laboratories, Inc.STAR S4 IR — JOHNSON & JOHNSON SURGICAL VISION, INC.IDESIGN RS — JOHNSON & JOHNSON SURGICAL VISION, INC.WAVESCAN WAVEFRONT SYSTEM — JOHNSON & JOHNSON SURGICAL VISION, INC.WaveLight — Alcon Laboratories, Inc.MEL 90 — Carl Zeiss Meditec AGMEL 80 — Carl Zeiss Meditec AGFinal Fit™ — NIDEK CO.,LTD.TECHNOLAS TENEO 317 — Technolas Perfect Vision GmbHNA — NIDEK CO.,LTD.WaveLight — Alcon Laboratories, Inc.IDESIGN ADVANCED WAVESCAN STUDIO — JOHNSON & JOHNSON SURGICAL VISION, INC.Quest™ — NIDEK CO.,LTD.WAVENET — Alcon Laboratories, Inc.WAVELIGHT EX500 EXCIMER LASER — Alcon Laboratories, Inc.IDESIGN RS — JOHNSON & JOHNSON SURGICAL VISION, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-10-21 | AMO Manufacturing USA, LLC | Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabl |
| 2017-02-01 | Nidek Inc | During treatment planning, the procedure was programmed with an unintended (wrong) correction. |
| 2015-03-24 | Nidek Inc | Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA. |
| 2013-09-16 | Abbott Medical Optics, Inc. | This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyrist |
| 2013-09-16 | Abbott Medical Optics, Inc. | This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyrist |
| 2013-09-16 | Abbott Medical Optics, Inc. | This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyrist |
| 2013-09-16 | Abbott Medical Optics, Inc. | This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyrist |
| 2013-05-28 | Abbott Medical Optics, Inc. | Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser. |
| 2013-05-28 | Abbott Medical Optics, Inc. | Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser. |
| 2013-05-28 | Abbott Medical Optics, Inc. | Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser. |
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