medical Class I Updated 2019-03-13

RVO 2.0, INC recalls Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Ma

Recalled Product

Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.


Hazard / Issue

During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.

Issued by

FDA

Affected States: NV, GA, NY, MN, TX, ND, AZ, VA, SD, IN, MA, MO, CA, NC, UT, IL, NH, OH, OK, FL, NJ, TN, MI, PA, HI, ID, KY, NE, AL, LA, CO, MD, MS, OR, WI, AR, WA
Lot/Code Info: All lots of unused product
View official government recall

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