Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported March 13, 2019
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Rvo 2.0, INC recalled Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, I… - a critical-severity action.
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, I… was recalled by Rvo 2.0, INC in March 13, 2019. Reason: During a post approval study the firm found there was an increased risk of corneal haze following the implant…. Check the official notice for the remedy. Verify recall #Z-0865-2019 with the FDA Devices before acting.
The recall
Rvo 2.0, INC issued this critical-severity FDA Devices recall-During a post approval study the firm found there was an increased risk of corneal haze following the implant….
- Critical
- severity level
- 3K units
- affected scope
- Class I
- classification
- March 13, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0865-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0865-2019) was formally reported on March 13, 2019, with the manufacturer initiating the action on November 13, 2018. It is classified under Critical severity (Class I), with a current status of Terminated. Rvo 2.0, INC is listed as the recalling firm, operating out of Aliso Viejo, CA. Federal records list the affected scope as 2869.
The documented reason for this recall is: During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2869
Related Recalls
6
0 from same agency
Product description
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
Reason for recall
During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0865-2019 |
| Date reported | March 13, 2019 |
| Date initiated | November 13, 2018 |
| Recalling firm | Rvo 2.0, INC |
| Firm location | Aliso Viejo, CA |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0865-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.. Recalled by Rvo 2.0, INC. Units affected: 2869.
Why was this product recalled? ▼
During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 13, 2019. Severity: Critical. Recall number: Z-0865-2019.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0865-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 13, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.