Raindrop Near Vision Inlay recall
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
Why was Raindrop Near Vision Inlay recalled?
During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots of unused product
- Product
- Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
- Recalling firm
- RVO 2.0, INC
- Quantity
- 2869
- Distribution
- U.S.: 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; No OUS (Foreign) Distribution.
- Recall date
- March 13, 2019
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)