Staar Surgical recalls EVO+VISIAN Implantable Collamer Lenses due to potential failure to meet specifications. Affected models include T1210975 through T1566889. Consumers should contact the company for details.
Their is a potential that intraocular implant devices may not meet specifications.
Staar Surgical is recalling specific models of EVO+VISIAN Implantable Collamer Lenses because they may not meet required specifications. This could lead to improper function of the lens, which is implanted in the eye.
The lenses may not meet the necessary specifications for proper function after implantation. This could result in the lens not performing as intended, potentially affecting vision or requiring additional corrective procedures.
People who have received one of the recalled lens models (T1210975 to T1566889) for eye surgery. Patients who have undergone cataract surgery with these lenses are most at risk.
Check the model number on the lens packaging or the device label. The affected models range from T1210975 to T1566889. These lenses were sold with specific reference codes starting with VTICM5_12.6.
Look for the model number on the lens packaging or device label to confirm if it is one of the recalled models (T1210975 to T1566889).
Reach out to Staar Surgical Company for further instructions on what to do with the recalled lenses.
The recall indicates a potential issue with meeting specifications, but the lenses are not inherently unsafe. Consumers should check if their model is affected and follow the manufacturer's instructions.
Check the model number on the lens packaging or device label. The affected models range from T1210975 to T1566889.
The recall does not specify an immediate replacement requirement. Contact Staar Surgical for guidance on next steps.
We’ve drafted a message you can send Staar Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0471-2024 — Staar Surgical Staar Surgical Hello, I own a Staar Surgical that is covered by recall Z-0471-2024 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.
