Staar Surgical recalls EVO+VISIAN Implantable Collamer Lenses due to potential failure to meet specifications. Affected models include T1307122, T1485436, and others. Consumers should contact for details.
Their is a potential that intraocular implant devices may not meet specifications.
Staar Surgical is recalling EVO+VISIAN Implantable Collamer Lenses because they may not meet required specifications. This could lead to improper eye function or vision issues if used without correction.
The lenses may not meet the required specifications for proper eye function. This could result in vision problems or the need for additional corrective procedures if the lens does not perform as intended.
Patients who have received the EVO+VISIAN Implantable Collamer Lens (REF: VTICM5_13.2) from Staar Surgical are most at risk. This recall affects individuals who have undergone cataract surgery with this specific lens type.
Check for the model codes listed in the recall: T1307122, T1485436, T1257531, T1365550, T1511722, T1187957, T1342243, T1367644, T1205475, or T1387400. These lenses were sold with the REF: VTICM5_13.2 label.
Reach out to Staar Surgical directly to confirm if your lens is affected and get instructions for next steps.
The recall states there is a potential that the lenses may not meet specifications, but it does not specify a risk of serious injury or death. This is considered a low-risk issue.
Check the model codes on your lens packaging or label. Affected models include T1307122, T1485436, T1257531, T1365550, T1511722, T1187957, T1342243, T1367644, T1205475, or T1387400.
The recall does not require immediate discontinuation of use. However, you should contact Staar Surgical to determine if your specific lens model needs correction.
We’ve drafted a message you can send Staar Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0472-2024 — Staar Surgical Staar Surgical Hello, I own a Staar Surgical that is covered by recall Z-0472-2024 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.
