FDAFebruary 7, 2017device
Raindrop Near Vision Inlay, Model# RD1-1
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
revision opticsrevision
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCMelville Direct Recalls Fiber Optic Christmas Trees Due to Fire Hazard (Recall Alert)2017-12-21
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