Reported Mar 13, 2019 · Terminated
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
Rvo 2.0, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RVO 2.0, INC · 26800 Aliso Viejo Pkwy · Aliso Viejo, CA · 92656-2625
Is this the product you have?
- Raindrop Near Vision Inlay
- REFRD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc
- Lot codes and dates
- All lots of unused product
- Amount recalled
- 2869
Where it was sold
Why it was recalled
Stop using this product now
During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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