With the United States experiencing a steady rise in its population aged 65 and over, the number of individuals susceptible to cataracts is increasing, placing pressures on device manufacturers and healthcare providers. This demographic shift, coupled with a push toward outcome-driven and patient‐centered care, is fundamentally altering the environment of the US Cataract Surgery Device Market. The MRFR report estimates the market was valued at USD 2.11 billion in 2023, is expected to rise to USD 2.5 billion in 2024, and projected to reach USD 4.5 billion by 2035, growing at a CAGR of 5.489% from 2025 to 2035.  However, several regulatory challenges remain. The U.S. Food and Drug Administration maintains stringent approval processes for novel cataract surgery devices, particularly for IOLs, femtosecond lasers, and viscoelastic agents. Safety concerns—such as biocompatibility of materials, precision of cutting, risk of infection, and postoperative complications—must be thoroughly addressed. In addition, getting reimbursement and insurance coverage for cutting-edge devices can be a hurdle, especially when cost or perceived benefit over existing technologies is not clear. Stakeholders must balance innovation with compliance, quality assurance, and effective clinical validation in real-world settings.

Regulatory compliance, cost of certification, and ensuring consistent quality across production are substantial obstacles. Manufacturers that can navigate these hurdles will likely gain market share, but those unable to invest sufficiently may be left behind in a field where patient safety and outcomes are closely scrutinized.