Staar Surgical AG is recalling seven units of its EVO+ Visian Toric Implantable Collamer Lens (TICL), model VTICM5, which are used to correct myopia and astigmatism. These lenses were incorrectly labeled as 12.1 mm in length when they are actually 12.6 mm. This error can lead to excessive vaulting in the eye, potentially causing serious complications like glaucoma or pupil issues. Patients with these specific serial numbers should contact their eye surgeon immediately to discuss necessary monitoring or lens replacement.
The oversized lenses may cause significant shallowing of the anterior chamber and reduced irido-corneal angles. This can lead to elevated eye pressure, angle-closure glaucoma, unreactive pupils, and the need for surgical removal or exchange of the lens.
Lenses labeled as 12.1 mm length but are actually 12.6 mm length.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.