Devices › Lens, guide, intraocular
Device brand name · Lens guide
Monarch Iol Delivery System: medical device reports filed with FDA
214 reports name it, 1999–2005. Manufacturer given most often on reports: Alcon Laboratories. Product code KYB.
- 214
- device reports naming the brand
- 0% of all MAUDE reports · about 8 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 92.5%
- classified as malfunction
- 81.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 214 reports that name the brand "Monarch Iol Delivery System" (lens guide), received between March 1999 and December 2005; the manufacturer given most often on reports is Alcon Laboratories. Spellings of one product vary from report to report.
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 malfunction (92.5%) and injury (7.5%); across all lens, guide, intraocular reports (product code KYB) death is recorded in 0% and malfunction in 81.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are sticking (55.6%), device damaged prior to use (24.3%) and failure to deliver (9.3%). The patient problems coded most often are eye injury, surgery, prolonged and surgical procedure, additional. 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 Monarch Iol Delivery System was received in the five years to August 2026; the latest was received in December 2005.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 8,704 reports carrying product code KYB. 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 |
|---|---|---|---|
| Sticking | 119 | 55.6% | 16.9% |
| Device damaged prior to usethe device was damaged before use | 52 | 24.3% | 7.6% |
| Failure to deliverthe device did not deliver the dose or item | 20 | 9.3% | 2.1% |
| Abnormal | 16 | 7.5% | 0.4% |
| Defective component | 10 | 4.7% | 2% |
| Entrapment of device | 5 | 2.3% | 0.4% |
| Tears, rips, holes in device, device material | 5 | 2.3% | 2.1% |
| Device remains implanted | 4 | 1.9% | 0.5% |
| Difficult to insertthe device was hard to insert | 4 | 1.9% | 3.1% |
| Explanted | 3 | 1.4% | 1.5% |
| Malfunction | 3 | 1.4% | 0.2% |
| Other (for use when an appropriate device code cannot be identified) | 3 | 1.4% | 3.3% |
| Breakthe device broke | 2 | 0.9% | 6.6% |
| Crackthe device cracked | 2 | 0.9% | 5.2% |
| Difficult to removethe device was hard to remove | 2 | 0.9% | 0.4% |
| Normal | 2 | 0.9% | 0% |
| Sharp/jagged/rough/etched/scratched | 2 | 0.9% | 0.2% |
| Split | 2 | 0.9% | 0.7% |
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 |
|---|---|---|
| Eye injury | 5 | 2.3% |
| Surgery, prolonged | 3 | 1.4% |
| Surgical procedure, additional | 3 | 1.4% |
| Corneal edema | 1 | 0.5% |
| Hypopyon | 1 | 0.5% |
| Membrane, breakage of | 1 | 0.5% |
| Other (for use when an appropriate patient code cannot be identified) | 1 | 0.5% |
| Rupture due to stress from capsular contracture | 1 | 0.5% |
| Surgical procedure, repeated | 1 | 0.5% |
| Tissue damage | 1 | 0.5% |
| Visual impairmentreduced vision | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Monarch Iol Delivery System | Product code KYB | All MAUDE reports |
|---|---|---|---|
| Reports | 214 | 8,704 | 26,136,888 |
| Share of that pool | — | 2.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 7.5% | 18.1% | 36.2% |
| Classified as malfunction | 92.5% | 81.5% | 62.3% |
| Filed by the manufacturer | 100% | 99.1% | 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."
Other brands with product code KYB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Monarch Iol Delivery System - Cartridge | 1,449 | 0 | 0% |
| AcrySof IQ Singlepiece IOL with ULTRASERT Delivery System | 1,878 | 244 | 0% |
| Microstaar Injector | 934 | 0 | 0% |
| Platinum 1 Series | 540 | 0 | 0% |
| AcrySof IQ Aspheric UV Absorbing IOLwith UltraSert Delivery System | 850 | 174 | 0% |
| Microstaar Injector Cartridge | 622 | 0 | 0% |
| Monarch Delivery System | 270 | 0 | 0% |
| Emerald | 294 | 10 | 0% |
| MONARCH IOL Delivery System, Injector, Unspecified | 173 | 50 | 0% |
| Easy Load Inserter | 600 | 0 | 0% |
| Monarch Iol Delivery System-Cartridge | 152 | 0 | 0% |
| Acrysof Iq Singlepiece Iol W/Ultrasert Delivery System | 150 | 0 | 0% |
| MONARCH IOL Delivery System, Cartridge | 220 | 26 | 0% |
| Microstaar Foam Tip Plunger | 251 | 0 | 0% |
| Alcon | 180 | 2 | 0% |
Ordered by report count for navigation only. 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 also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Monarch Iol Delivery System reports
How many FDA reports name Monarch Iol Delivery System?
214 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?
malfunction (92.5%) and injury (7.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
sticking (55.6%), device damaged prior to use (24.3%), failure to deliver (9.3%), abnormal (7.5%) and defective component (4.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Monarch Iol Delivery System 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.