Reported Mar 29, 2017 · Terminated
Raindrop Near Vision Inlay, Model# RD1-1
Revision Optics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Revision Optics Inc · 25651 Atlantic Ocean Dr Ste A1 · Lake Forest, CA · 92630-8835
Is this the product you have?
- Raindrop Near Vision Inlay, Model# RD1-1
- Lot codes and dates
- multiple lots since 08/01/2016
- Amount recalled
- 1,279 devices
Where it was sold
Why it was recalled
ReVision Optics has updated the instructions for use (IFU) for the Raindrop Near Vision Inlay to emphasize that only Balanced Salt Solution (BSS) may be used to irrigate under the flap and that topical medications or lubricants should not be administered until centration of the inlay and proper flap positioning has been confirmed at the slit lamp.
This product could cause temporary or reversible health problems — stop using it.
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