Staar Surgical recalls EVO VISIAN Implantable Collamer Lenses (REF VICMO12.1) due to potential failure to meet specifications. Affected units have specific UDI and serial numbers.
Their is a potential that intraocular implant devices may not meet specifications.
Staar Surgical is recalling EVO VISIAN Implantable Collamer Lenses (REF VICMO1:1) because they may not meet required specifications. This could affect eye health if the lens fails during use.
The lenses may not meet required specifications, which could lead to failure during use. This might cause eye health issues if the lens does not function properly.
People who have received the EVO VISIAN Implantable Collamer Lens (REF VICMO12.1) from Staar Surgical are affected. Those with the specific UDI and serial numbers listed in the recall are most at risk.
Check for the UDI: (01)00841542121972 and serial number S1734493 on the lens packaging or device. The recall applies to EVO VISIAN Implantable Collamer Lenses with REF VICMO12.1.
Look for the UDI (01)00841542121972 and serial number S1734493 on the lens packaging or device.
The recalled lens is EVO VISIAN Implantable Collamer Lens with REF VICMO12.1.
Check for the UDI (01)00841542121972 and serial number S1734493 on the lens packaging or device.
The recall does not specify a remedy, so contact Staar Surgical directly for guidance.
We’ve drafted a message you can send Staar Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0468-2024 — Staar Surgical Staar Surgical Hello, I own a Staar Surgical that is covered by recall Z-0468-2024 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.
