Raindrop Near Vision Inlay — Class II medical device recall Z-1518-2017
Terminated recall by Revision Optics Inc, reported 2017-03-29, distributed in AL, AZ, CA, FL, GA, HI, IL, IN…. ReVision Optics has updated the instructions for use (IFU) for the Raindrop Near Vision Inlay to emphasize tha
| Recall number | Z-1518-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Revision Optics Inc, Lake Forest, CA, United States |
| Recall initiated | 2017-02-07 |
| Classified | 2017-03-21 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2017-06-21 |
| Distributed | AL, AZ, CA, FL, GA, HI, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, SD, TN, TX, UT, WA |
| Quantity | 1,279 devices |
| Model numbers | RD1-1 |
Product
Raindrop Near Vision Inlay, Model# RD1-1
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1518-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.