Rayner recalls RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems with mislabeled outer packages containing different IOL strength. Affected units have specific batch and serial numbers. Contact Rayner for details.
The outer package is mislabeled and the package contains a different IOL strength.
Rayner is recalling certain RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems because the outer packaging incorrectly labels the lens strength. This mismatch could lead to incorrect lens placement during surgery, potentially causing vision issues.
The outer packaging mislabels the lens strength, meaning the actual lens strength inside may differ from what's printed on the box. This could result in incorrect lens placement during eye surgery, potentially causing vision problems or requiring additional corrective procedures.
Surgical patients who received the recalled RayOne IOL systems during eye surgery. Surgeons and medical facilities using these specific units are most at risk.
Check for outer cartons labeled 'Rayner RayOne EMV US, REF RAO200E' with specific lens strengths: +19.00D (Batch #012183745) or +21.00D (Batch #012183845). Serial numbers and expiration dates are also listed in the recall details.
Look for outer cartons labeled with specific lens strengths: +19.00D or +21.00D, along with batch numbers and serial numbers as listed in the recall.
The recall states the outer package is mislabeled, so the actual lens strength may differ from what's printed. The correct strength depends on the specific batch and serial numbers provided in the recall.
Check for outer cartons labeled 'Rayner RayOne EMV US, REF RAO200E' with lens strengths +19.00D (Batch #012183745) or +21.00D (Batch #012183845), and corresponding serial numbers as listed in the recall.
The recall does not specify a remedy, so no action is required beyond checking if your product matches the described labels and batch numbers.
We’ve drafted a message you can send Rayner to request your refund or repair — edit it as you like.
Subject: Recall Z-1338-2022 — Rayner Rayner Hello, I own a Rayner that is covered by recall Z-1338-2022 from Rayner. 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.
