Raindrop Near Vision Inlay Recalled Due to Increased Risk of Corneal Haze
RVO 2.0, Inc. is recalling Raindrop Near Vision Inlays because a post-approval study found an increased risk of corneal haze following implantation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a reported increased risk of a specific adverse effect (corneal haze) identified during a post-approval study. While no specific injury counts or fatalities are reported in the source text, the risk of harm to a medical device patient places this in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported in specific counts.
Plain-English summary
RVO 2.0, Inc. is recalling the Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only. The recall involves 2,869 units of unused product across all lots. The device is distributed in 36 U.S. states, including California, Texas, and New York, with no foreign distribution reported.
The recall was initiated after a post-approval study conducted by the firm identified an increased risk of corneal haze following the implantation of the device. This finding prompted the company to remove the product from the market to ensure patient safety.
Consumers and healthcare providers who have purchased or received this product should contact RVO 2.0, Inc. for further instructions on how to proceed. Patients who have already had the device implanted should consult their eye care provider regarding the potential risk of corneal haze.
The recalled product
- Product
- Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
- Manufacturer
- RVO 2.0, INC
- Hazard
- Affected units
- 2,869
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots of unused product
Distribution
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