Home › Alcon Laboratories, Inc. › WAVELIGHT REFRACTIVE SUITE
WAVELIGHT REFRACTIVE SUITE
Alcon Laboratories, Inc. · Model 8065990606 · UDI-DI 00380659906060
LZS
Prescription
0
510(k) clearances
13,749
Adverse events (12 deaths)
29
Recalls
10
Facilities
Description
ALLEGRO ANALYZER. The WaveLight® Topolyzer™ VARIO and WaveLight® Analyzer II diagnostic devices are measuring instruments intended for use in eye examinations to measure corneal topography. Data from these systems may be exported and used to support refractive surgical procedures with the WaveLight® laser systems.
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 enabled, and improperly p |
| 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 thyristor component on the |
| 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 thyristor component on the |
| 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 thyristor component on the |
| 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 thyristor component on the |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.