ReVision Optics Raindrop Near Vision Inlay Recall: Increased Corneal Haze Risk

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Recalling firmRVO 2.0, INC26800 Aliso Viejo Pkwy, Ste 160 · Aliso Viejo, CA 92656-2625

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✎ GovInfoNow plain-language explainer

What happened, in plain English

ReVision Optics is recalling unused Raindrop Near Vision Inlays (RD1-1) because studies found a higher risk of corneal haze after implantation. This could affect eye health if the device is used without proper medical supervision.

Why it’s dangerous

The device can cause corneal haze, a cloudy layer on the eye's surface, which may lead to vision problems. This risk was identified during post-approval studies and is specific to the inlay's implantation process.

Who’s affected

People who have been prescribed this inlay by a doctor and have unused products. Those with eye conditions requiring near vision correction are most at risk.

How to tell if you have this one

Check for the product name 'Raindrop Near Vision Inlay', model 'RD1-1', and the label 'Sterile, Rx Only'. All unused products are included in this recall.

Brand
ReVision Optics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the model number RD1-1 and the label 'Sterile, Rx Only' on unused products.

✎ GovInfoNow

Questions people ask

Is this device safe to use?

The recall indicates an increased risk of corneal haze after implantation, so it is not recommended for use without medical supervision.

How can I tell if I have the recalled product?

Check for the model number RD1-1 and the label 'Sterile, Rx Only' on unused products.

What should I do if I have this product?

The recall does not specify a remedy, so contact ReVision Optics for further instructions.

Take action

Contact ReVision Optics

We’ve drafted a message you can send ReVision Optics to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0865-2019 — ReVision Optics ReVision Optics

Hello,

I own a ReVision Optics that is covered by recall Z-0865-2019 from ReVision Optics.

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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Where this comes from

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.

Official source: FDA Recall #Z-0865-2019 (November 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0865-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

RVO 2.0, INC recalls Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.

Lower-risk recall