Raindrop Near Vision Inlay Recall for Updated Instructions for Use
ReVision Optics is recalling 1,279 Raindrop Near Vision Inlays to update instructions for use regarding irrigation and medication timing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a documentation update to the instructions for use to prevent potential procedural errors, which aligns with the rubric for moderate severity involving labeling or documentation issues.
Plain-English summary
ReVision Optics is recalling 1,279 units of the Raindrop Near Vision Inlay, Model# RD1-1. The recall was initiated to update the instructions for use (IFU) for the device.
The updated instructions emphasize that only Balanced Salt Solution (BSS) may be used to irrigate under the flap. Additionally, the IFU now specifies 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.
The affected devices were distributed in the United States across multiple states, including 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, and WA. The recall covers multiple lots manufactured since August 1, 2016. Consumers and healthcare providers should refer to the updated instructions for use provided by the manufacturer.
The recalled product
- Product
- Raindrop Near Vision Inlay, Model# RD1-1
- Manufacturer
- Revision Optics Inc
- Category
- Medical Device — Ophthalmic
- Hazard
- Affected units
- 1,279
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- multiple lots since 08/01/2016
Distribution
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