Company: STAA
Filing Date: 2025-09-29
Form Type: DFAN14A
Source: 0001213900-25-093211
Chunk: 14

Company: STAAR SURGICAL CO
Filing Date: 2025-09-29
Form: DFAN14A
Chunk 14
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 Draft Guidance for LASIK Patient Labeling highlighted just how common early complications can be:

| ● | Up                                                                                               
 to 85% of patients report dry eye symptoms at one week post-surgery, and 27% still have symptoms 
 at six months                                                                                    |

| ● | 41%                                                                                         
 report glare, halos, starbursts, or double vision at six months, with about 4% calling them 
 “very” or “extremely” bothersome                                                            |

<div align='center'>4</div>

| ● | Around                                                     
 17% still use eye drops daily for dry eye five years later |

The guidance also explicitly warns of rare but severe outcomes, including chronic pain, corneal ectasia, and even depression or suicidality, and recommends a patient checklist requiring patients to initial each risk before surgery.

Under the FDA’s guidance document remains a comment section filled with LASIK horror stories, including Steven Jantzen, who said, “LASIK ruined my life.” Eye doctors under the thread remained more positive on the surgery, with Trevor Woodhams saying, “It was one of the best decisions of my life. It has been over 20 years and I still have near 20/20 vision. I have also performed LASIK on my two children who are now in their 30s.”

In one widely reported case, 26-year-old police officer Ryan Kingerski took his own life after experiencing unrelenting pain, light sensitivity, and visual disturbances following LASIK.

The criticism of LASIK has even reached the people who helped bring it to market. Dr. Morris Waxler, the former head of the FDA branch that approved LASIK in the 1990s, has since said publicly that the agency “got it wrong” on safety. In a 2011 citizen petition to the FDA, Waxler asked the agency to withdraw its LASIK approvals, citing “widespread, severe adverse events” that he believed were underreported at the time of approval. In later interviews with ABC News and CBS, Waxler said, “I think we screwed up,” and “I would not recommend LASIK to anyone.”

ICL procedures, by contrast, do not involve reshaping the cornea, making them suitable for patients with mid-to-high myopia or thin corneas. While ICL carries risks such as cataract formation or elevated intraocular pressure, no suicides have been linked to the surgery, and complication rates are considered low when performed by experienced surgeons.

The