Staar Surgical recalls EVO+VISIAN Implantable Collamer Lenses due to potential failure to meet specifications. Affected models include T1438478, T1224985, T1259704, T1370322, and T1508546. No remedy is specified in the recall notice.
Their is a potential that intraocular implant devices may not meet specifications.
Staar Surgical is recalling specific EVO+VISIAN Implantable Collamer Lenses that may not meet specifications. This could lead to potential failure of the lens implant, which is a serious medical device. Affected customers should contact the manufacturer for details.
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 after implantation, potentially affecting vision correction. However, the exact mechanism of failure is not detailed in the recall notice.
Patients who have received the recalled EVO+VISIAN Implantable Collamer Lenses (models T1438478, T1224985, T1259704, T1370322, or T1508546) are most at risk. These lenses are used for vision correction in eye surgery.
Check the product label for the model numbers T1438478, T1224985, T1259704, T1370322, or T1508546. These lenses were sold as Phakic Toric Intraocular lenses for vision correction procedures.
Reach out to Staar Surgical Company directly to confirm if your lens model is affected and get further instructions.
The recall states there is a potential that the intraocular implant devices may not meet specifications, which could lead to failure of the lens implant.
The affected models are T1438478, T1224985, T1259704, T1370322, and T1508546.
The recall notice does not specify any remedy or action steps beyond contacting the manufacturer.
We’ve drafted a message you can send Staar Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0473-2024 — Staar Surgical Staar Surgical Hello, I own a Staar Surgical that is covered by recall Z-0473-2024 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.
