Staar Surgical recalls EVO+VISIAN Implantable Collamer Lenses due to potential failure to meet specifications. Affected units have specific serial numbers; contact for details.
Their is a potential that intraocular implant devices may not meet specifications.
Staar Surgical is recalling certain EVO+VISIAN Implantable Collamer Lenses because they may not meet required specifications. This could affect eye health if used without proper function.
The lenses may not meet required specifications, which could lead to improper eye function. However, the recall does not specify a risk of serious injury or death in normal use.
People who have received the recalled EVO+VISIAN Implantable Collamer Lenses (REF:VICM5_12.1) for eye surgery. Those with the specific serial numbers listed are most at risk.
Check the serial number on the lens packaging or device. Affected units have specific serial numbers listed in the recall notice, such as S1894967 or S1954863.
Look for the serial number on the lens packaging or device to confirm if it matches the listed serial numbers in the recall.
The recall does not require immediate stopping of use; it only asks to check if the lens is affected.
Contact Staar Surgical directly to confirm if your lens is affected and get further instructions.
The recall states a potential failure to meet specifications but does not mention a risk of serious injury in normal use.
We’ve drafted a message you can send Staar Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0464-2024 — Staar Surgical Staar Surgical Hello, I own a Staar Surgical that is covered by recall Z-0464-2024 from Staar Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
