Company: STAA
Filing Date: 2025-09-29
Form Type: DFAN14A
Source: 0001213900-25-093211
Chunk: 13

Company: STAAR SURGICAL CO
Filing Date: 2025-09-29
Form: DFAN14A
Chunk 13
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 Collamer                                                                                         
 Material: a proprietary collagen-copolymer blend designed for optical clarity, biocompatibility, 
 and stability over decades                                                                       |

| ● | Lens                                                                                         
 Design: including the EVO and EVO+ models with central port technology, a key differentiator 
 from older ICL designs                                                                       |

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| ● | Delivery                                                                        
 Systems: including preloaded, single-use injector systems that simplify surgery 
 and reduce contamination risk                                                   |

STAAR is the exclusive global manufacturer of the EVO ICL family and controls more than 90% of the dollar share of the global market. No competitor can legally produce a direct substitute without licensing STAAR’s IP, a moat that could last well into the 2030s based on current patent life. Together, this history and patent protection strengthen the argument that STAAR is not just a growth story but a market leader with a de-risked, proprietary technology platform poised for wider adoption.

Clinical Outcomes: A Decades-Long Track Record

Millions of ICLs have been implanted worldwide, and multiple independent studies confirm the lens’ long-term safety and effectiveness:

| ● | 10-Year                                                                              
 Follow-Up Study: Found no infections or cataracts, very few reoperations, and stable 
 vision over a decade                                                                 |

| ● | Large-Scale                                                                      
 Study (1,800+ Eyes): Showed most patients ended up very close to perfect vision, 
 with temporary side effects like mild pressure changes resolving on their own    |

| ● | Systematic                                                                      
 Review (3,000+ Eyes): Found consistently high safety and efficacy scores across 
 dozens of studies                                                               |

| ● | Lens                                                                               
 Adjustments (<0.3% of Cases): Fewer than 3 in 1,000 eyes needed the lens realigned 
 or swapped out, and those cases were successfully fixed                            |

The Dark Side of LASIK

LASIK, or laser-assisted in situ keratomileusis, remains the world’s most common vision correction surgery, performed more than 40 million times globally. It involves cutting a flap in the cornea, reshaping the underlying tissue, and sealing the flap back in place to correct refractive errors. Around 95% of patients achieve 20/25 vision or better, a level sufficient for most daily activities.

But the 5% who suffer persistent complications face dry eyes, glare, halos, and night vision problems, sometimes permanently. The FDA’s 2022