Device brand name · Corneal inlay

Raindrop Near Vision Inlay: medical device reports filed with FDA

206 reports name it, 2016–2018. Manufacturer given most often on reports: Revision Optics. Product code LQE.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

206
device reports naming the brand: 0% of all MAUDE reports · about 21 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 15.5%
classified as malfunction: 10.4% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

206 medical device reports received by FDA name the brand "Raindrop Near Vision Inlay" (corneal inlay); the manufacturer given most often on reports is Revision Optics; received from September 2016 to November 2018. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (84.5%) and malfunction (15.5%); across all implant, corneal, refractive reports (product code LQE) death is recorded in 0% and malfunction in 10.4%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are device dislodged or dislocated (31.1%), contamination (2.4%) and labelling, instructions for use or training problem (2.4%). The patient problems coded most often are loss of vision, corneal clouding/hazing and visual disturbances. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

No report naming Raindrop Near Vision Inlay was received in the five years to August 2026; the latest was received in November 2018.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury84.5%174

Malfunction15.5%32

Other0%0

Not given0%0

Who filed the report

Manufacturer report96.1%198

Voluntary report3.9%8

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 335 reports carrying product code LQE. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Device dislodged or dislocated	64	31.1%	20.3%
Contamination	5	2.4%	1.5%
Labelling, instructions for use or training problem	5	2.4%	1.5%
Biological environmental factor	4	1.9%	1.2%
Malposition of device	2	1%	1.2%
Positioning problem	2	1%	0.6%
Wrinkled	2	1%	0.9%
Device contamination with chemical or other material	1	0.5%	0.3%
Environmental particulates	1	0.5%	0.3%
Material fragmentation	1	0.5%	0.3%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
Loss of vision	80	38.8%
Corneal clouding/hazing	78	37.9%
Visual disturbances	35	17%
Blurred vision	17	8.3%
Halo	14	6.8%
Visual impairmentreduced vision	13	6.3%
Keratitis	11	5.3%
Dry eye(s)	9	4.4%
Corneal edema	8	3.9%
Corneal scar	8	3.9%
Inflammationinflammation	8	3.9%
Corneal ulcer	5	2.4%
Corneal abrasion	4	1.9%
Foreign body sensation in eye	3	1.5%
Tissue damage	3	1.5%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Raindrop Near Vision Inlay	Product code LQE	All MAUDE reports
Reports	206	335	26,136,888
Share of that pool	—	61.5%	0%
Classified as death, per 1,000 reports	0	0	9
Classified as injury	84.5%	88.7%	36.2%
Classified as malfunction	15.5%	10.4%	62.3%
Filed by the manufacturer	96.1%	85.4%	94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Questions about Raindrop Near Vision Inlay reports

How many FDA reports name Raindrop Near Vision Inlay?

206 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

injury (84.5%) and malfunction (15.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device dislodged or dislocated (31.1%), contamination (2.4%), labelling, instructions for use or training problem (2.4%), biological environmental factor (1.9%) and malposition of device (1%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (96.1%) and voluntary reports (3.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Raindrop Near Vision Inlay was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.