Devices › Lens, guide, intraocular
Device brand name · Intraocular lens guide
Microstaar Injector Cartridge: medical device reports filed with FDA
622 reports name it, 2003–2012. Manufacturer given most often on reports: Staar Surgical. Product code KYB.
- 622
- device reports naming the brand
- 0% of all MAUDE reports · about 27 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 83.1%
- 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 622 reports that name the brand "Microstaar Injector Cartridge" (intraocular lens guide), received between September 2003 and June 2012; the manufacturer given most often on reports is Staar Surgical. 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 (83.1%), injury (15.9%) and other (0.8%); 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 lens, damaged by cartridge (33.1%), lens (iol), torn, split, cracked (32.6%) and haptic damaged in delivery system (15.6%). The patient problems coded most often are surgical incision, enlargement of, surgical procedure and no patient involvement. 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 Microstaar Injector Cartridge was received in the five years to August 2026; the latest was received in June 2012.
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 |
|---|---|---|---|
| Lens, damaged by cartridge | 206 | 33.1% | 2.5% |
| Lens (iol), torn, split, cracked | 203 | 32.6% | 4.9% |
| Haptic damaged in delivery system | 97 | 15.6% | 2.9% |
| Other (for use when an appropriate device code cannot be identified) | 93 | 15% | 3.3% |
| Lens damaged in delivery system | 66 | 10.6% | 3.6% |
| Lens, stuck in cartridge | 47 | 7.6% | 0.9% |
| Lens replacement | 46 | 7.4% | 1.8% |
| Implant, removal of | 32 | 5.1% | 0.9% |
| Replace | 24 | 3.9% | 1.4% |
| Difficult to insertthe device was hard to insert | 20 | 3.2% | 3.1% |
| Device, removal of (non-implant) | 17 | 2.7% | 0.8% |
| Explanted | 17 | 2.7% | 1.5% |
| Haptic(s), broken | 17 | 2.7% | 1.2% |
| Tears, rips, holes in device, device material | 17 | 2.7% | 2.1% |
| Device remains implanted | 16 | 2.6% | 0.5% |
| Haptic(s), bent | 12 | 1.9% | 1.3% |
| Failure to advance | 9 | 1.4% | 3.3% |
| Crackthe device cracked | 7 | 1.1% | 5.2% |
| Defective devicethe device was defective | 7 | 1.1% | 3% |
| Physical resistance | 7 | 1.1% | 0.4% |
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 |
|---|---|---|
| Surgical incision, enlargement of | 74 | 11.9% |
| Surgical procedure | 63 | 10.1% |
| No patient involvement | 54 | 8.7% |
| Therapy/non-surgical treatment, additional | 15 | 2.4% |
| Foreign body, removal of | 10 | 1.6% |
| Membrane, breakage of | 5 | 0.8% |
| Surgical procedure, additional | 4 | 0.6% |
| Surgical procedure, repeated | 4 | 0.6% |
| Vitrectomy | 4 | 0.6% |
| Capsular bag tear | 2 | 0.3% |
| Corneal edema | 2 | 0.3% |
| Bleeding | 1 | 0.2% |
| Lens, replacement of | 1 | 0.2% |
| Surgical procedure, delayed | 1 | 0.2% |
| Thromboembolism | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Microstaar Injector Cartridge | Product code KYB | All MAUDE reports |
|---|---|---|---|
| Reports | 622 | 8,704 | 26,136,888 |
| Share of that pool | — | 7.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 15.9% | 18.1% | 36.2% |
| Classified as malfunction | 83.1% | 81.5% | 62.3% |
| Filed by the manufacturer | 99.7% | 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% |
| Monarch Delivery System | 270 | 0 | 0% |
| Emerald | 294 | 10 | 0% |
| Monarch Iol Delivery System | 214 | 0 | 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 Microstaar Injector Cartridge reports
How many FDA reports name Microstaar Injector Cartridge?
622 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 (83.1%), injury (15.9%) and other (0.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
lens, damaged by cartridge (33.1%), lens (iol), torn, split, cracked (32.6%), haptic damaged in delivery system (15.6%), other (for use when an appropriate device code cannot be identified) (15%) and lens damaged in delivery system (10.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%) and voluntary reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Microstaar Injector Cartridge 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.