Staar Surgical recalls EVO+VISIAN Implantable Collamer Lenses with specific serial numbers due to potential failure to meet specifications. Consumers should check their lens serial numbers.
Their is a potential that intraocular implant devices may not meet specifications.
Staar Surgical is recalling certain EVO+VISIAN Implantable Collamer Lenses (phakic intraocular lenses) because they may not meet required specifications. This could lead to improper function or failure of the lens implant.
The recall states there is a potential that the intraocular implant devices may not meet specifications. This could mean the lenses might not function properly or could fail in the eye, potentially causing vision issues or complications after surgery.
People who have received the recalled EVO+VISIAN Implantable Collamer Lenses (phakic intraocular lenses) with the specific serial numbers listed in the recall. Those who have had surgery using these lenses are most at risk.
Check the serial number on your lens. The recalled lenses have specific serial numbers listed in the recall notice, which include a pattern of numbers and letters starting with S followed by a series of digits and parentheses.
Look for the serial number on your lens, which follows the pattern shown in the recall list (e.g., S1721405).
No action is needed if your lens is not on the list of recalled serial numbers.
Compare your lens serial number to the list of specific serial numbers provided in the recall notice.
The recall does not specify a remedy, so contact Staar Surgical directly for further instructions.
We’ve drafted a message you can send Staar Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0466-2024 — Staar Surgical Staar Surgical Hello, I own a Staar Surgical that is covered by recall Z-0466-2024 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.
