ICL Surgery's Growing Risks and Market Implications: A Cautionary Outlook for Ophthalmic Tech Investors

The refractive surgery sector has long been a bright spot in healthcare innovation, with Implantable Collamer Lens (ICL) procedures gaining traction as a premium alternative to LASIK. However, emerging clinical and financial data paint a more nuanced picture. While the ICL market is projected to grow at a robust compound annual growth rate (CAGR) of 6.4–12% through 2033, rising complications such as elevated intraocular pressure (IOP), cataract risk, and patient dissatisfaction are casting shadows over its long-term viability. For investors, the key question is whether these risks will be mitigated by technological advancements or amplify regulatory and market pressures.

Elevated IOP: A Persistent Clinical and Market Concern

Elevated IOP remains one of the most frequently reported complications following ICL surgery. A 2025 analysis of the FDA's MAUDE database revealed that 10.8% of post-ICL complications involved IOP elevation, often occurring within the first postoperative day due to retained viscoelastic material. While long-term studies suggest that IOP elevation typically remains within normal limits for most patients, glaucoma developed in 1.5% of cases. Notably, the EVO+ ICL model, an updated version of STAAR Surgical's flagship product, has shown a higher incidence of IOP-related events compared to earlier models.

These findings have not gone unnoticed by the market. Despite the ICL sector's growth projections, companies like STAAR Surgical have faced headwinds. In Q3 2025, STAAR reported $94.7 million in net sales, but its Chinese market-accounting for roughly half of its revenue-has seen declining procedure volumes and inventory challenges. The company's pursuit of a merger with Alcon, now offering $30.75 per share, underscores the urgency to address these risks.

Cataract Risk and Patient Dissatisfaction: Underestimated Liabilities

Cataract formation, though relatively rare, poses another significant risk. A 2025 study found that 1.96% of ICL patients developed cataracts within five years post-surgery, with older patients and those with high myopia (-12 dioptres or more) at greater risk. While newer Aquaport-design ICLs have reduced cataract rates, the association between ICL implantation and long-term lens opacity remains a concern for both clinicians and investors.

Patient dissatisfaction, meanwhile, is a growing issue across refractive and cataract surgeries. For ICL procedures, dissatisfaction rates linked to dry eye disease (DED) and ocular surface dysfunction are alarmingly high. Over 80% of patients experience some degree of DED postoperatively, leading to symptoms like glare, halos, and discomfort despite achieving 20/20 vision. In cataract surgery, dissatisfaction rates with presbyopia-correcting intraocular lenses (IOLs) reach 18.5%, driven by factors like corneal astigmatism and preoperative myopia. These trends highlight the importance of preoperative patient screening and postoperative care-a challenge for companies relying on volume-driven growth.

Regulatory Scrutiny and Market Dynamics

Regulatory scrutiny is intensifying as adverse event (AE) reports climb. The MAUDE database logged over 17,000 ICL-related AEs between 2015 and 2023, with blurred vision, elevated IOP, and rare but severe complications like endophthalmitis dominating the data. While no specific policy changes have targeted ICLs, the broader medical aesthetics sector is witnessing stricter oversight, including enhanced disclosure requirements and scope-of-practice regulations. For ophthalmic tech firms, this environment could lead to increased post-market surveillance and potential product recalls, further pressuring margins.

Financially, the ICL market's resilience is partly attributable to technological innovations. Features like STAAR's CentraFlow® technology-which claims a 0% incidence of visually significant anterior subcapsular cataract-have bolstered market confidence. However, with procedure costs ranging from $3,000 to $5,000 per eye, affordability and complication rates could deter price-sensitive patients, particularly in emerging markets.

Investor Implications: Balancing Growth and Risk

For investors, the ICL sector presents a paradox: strong growth fundamentals coexist with rising clinical and regulatory risks. While the global ICL market is valued at $20.77 billion in 2025 and expected to reach $27 billion by 2029, companies must navigate a landscape where patient safety and satisfaction are paramount. STAAR Surgical's merger with Alcon, for instance, reflects a strategic pivot to leverage Alcon's scale and resources to mitigate standalone risks.

However, the path forward is not without challenges. High procedure costs, competition from alternatives like LASIK, and the potential for regulatory intervention could dampen growth. Investors should closely monitor clinical trial outcomes for next-generation ICLs, as well as regulatory developments in key markets like China and the U.S.

Conclusion: Proceed with Caution

The ICL market's long-term viability hinges on its ability to address complications like elevated IOP, cataract risk, and patient dissatisfaction. While technological advancements and market expansion offer upside potential, investors must remain vigilant. Companies that prioritize patient-centric innovations-such as improved ocular surface management and predictive risk modeling-will likely outperform peers. For now, the sector remains a high-growth opportunity, but one that demands careful due diligence and a balanced assessment of clinical and financial risks.