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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device."
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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