Staar Surgical recalls EVO+VISIAN Implantable Collamer Lenses with specific serial numbers due to potential failure to meet specifications. Affected patients should contact the company for details.
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) that may not meet specifications. This could lead to improper function or failure of the lens implant.
The recall states there is a potential that these intraocular implant devices may not meet specifications. This could result in improper function or failure of the lens implant, potentially affecting vision or requiring additional surgical intervention.
Patients who have received the recalled EVO+VISIAN lenses with the listed serial numbers are affected. The risk is primarily for individuals who have undergone cataract surgery using these specific lenses.
Check the serial number on your lens, which appears in the format S1731386 or similar followed by a long code. The specific serial numbers are listed in the recall notice.
Look for the serial number on your lens, which is listed in the recall notice as a specific code format.
Staar Surgical is recalling specific EVO+VISIAN Implantable Collamer Lenses (phakic intraocular lenses) that may not meet specifications.
Check the serial number on your lens against the list of affected serial numbers provided in the recall notice.
The recall does not specify a remedy, so affected patients should 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-0465-2024 — Staar Surgical Staar Surgical Hello, I own a Staar Surgical that is covered by recall Z-0465-2024 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.
