🔍 RecallPedia

Raindrop Near Vision Inlay, Model# RD1-1

Class I - Dangerous
🏥 Medical Devices Recalled: February 7, 2017 Revision Optics Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    multiple lots since 08/01/2016
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Revision Optics Inc
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Raindrop Near Vision Inlay, Model# RD1-1

Product Codes/Lot Numbers:

multiple lots since 08/01/2016

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1518-2017