Oertli Instrumente Receives FDA Clearance for Faros Anterior Cataract Surgery System

Oertli Instrumente AG announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its globally established Faros anterior cataract surgery system. This milestone underscores Oertli's expansive global presence and unwavering commitment to delivering advanced and reliable surgical equipment worldwide.

Compact Design and Rapid Setup

The Faros system is distinguished by its compact design and rapid operational readiness, occupying minimal space in operating rooms. It boasts a setup time of under one minute, making it exceptionally suited for integration into office-based surgeries. Its precision in fluid or vacuum control allows for adaptability to varying cataract hardness, rendering it a versatile choice for eye surgeons.

"With millions of cataract surgeries successfully performed, Faros has earned a reputation for precision, robustness, and effectiveness, contributing to dependable surgical outcomes worldwide," noted a spokesperson for Oertli. The system's slim footprint and quick setup capability enhance operational efficiency, enabling healthcare facilities to optimize their surgical schedules.

Comprehensive FDA Clearance

The recent 510(k) clearance extends availability of the comprehensive Faros and CataRhex 3 device families across nearly all markets, ensuring compliance with the latest safety standards, including stringent cybersecurity norms. This approval encompasses all consumables essential for cataract surgery and emergency vitrectomy, providing surgeons with a complete suite of tools for comprehensive eye care.

Leadership and Innovation

Thomas Bosshard, Co-CEO of Oertli Instrumente AG, expressed enthusiasm about introducing Faros to the U.S. market: "We are excited to bring Faros to the United States, offering American ophthalmologists a system that integrates seamlessly into their operating theatres and supports the latest standards of patient care. This approval is not just a certification; it's a testament to our pursuit of excellence and innovation in eye surgery."

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