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WaveLight
Alcon Laboratories, Inc. · Model 8065990941 · UDI-DI 00380659909412
OOE
Prescription
10
510(k) clearances
4,829
Adverse events
8
Recalls
28
Facilities
Description
WAVELIGHT FS200
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 |
| 2018-05-09 | Johnson & Johnson Surgical Vision Inc | Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown o |
| 2018-01-21 | SIE AG, Surgical Instrument Engineering | This Correction is being initiated based on a customer complaint received on November 16, 2017 which indicated a complication with a cataract procedure. An investigation completed |
| 2016-04-14 | Alcon Research, Ltd. | Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as an u |
| 2015-02-20 | Optimedica Corporation | Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both eyes have the same p |
| 2015-02-20 | Abbott Medical Optics, Inc. | Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation. |
| 2014-03-14 | Alcon LenSx, Inc. | Alcon LenSx received reports of unexpected downward motion of the gantry. |
| 2013-12-20 | Optimedica Corporation | Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, which may manifest |
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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.