Devices › Lens, guide, intraocular
Device brand name · Surgical adjuncts
Platinum 1 Series: medical device reports filed with FDA
540 reports name it, 2014–2021. Manufacturer given most often on reports: Abbott Medical Optics. Product code KYB.
- 540
- device reports naming the brand
- 0% of all MAUDE reports · about 44 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 89.3%
- 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 540 reports that name the brand "Platinum 1 Series" (surgical adjuncts), received between February 2014 and February 2021; the manufacturer given most often on reports is Abbott Medical Optics. 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 (89.3%) and injury (10.7%); 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 crack (19.1%), device contamination with chemical or other material (18.1%) and break (14.6%). The patient problems coded most often are no patient involvement, edema and capsular bag tear. 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 Platinum 1 Series was received in the five years to August 2026; the latest was received in February 2021.
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 |
|---|---|---|---|
| Crackthe device cracked | 103 | 19.1% | 5.2% |
| Device contamination with chemical or other material | 98 | 18.1% | 2.3% |
| Breakthe device broke | 79 | 14.6% | 6.6% |
| Contamination | 71 | 13.1% | 1.7% |
| Difficult or delayed positioning | 43 | 8% | 0.7% |
| Positioning failure | 42 | 7.8% | 0.9% |
| Failure to eject | 35 | 6.5% | 3.7% |
| Split | 21 | 3.9% | 0.7% |
| Material deformation | 19 | 3.5% | 0.9% |
| Bent | 13 | 2.4% | 0.5% |
| Device damaged by another device | 12 | 2.2% | 7% |
| Device operates differently than expectedthe device behaved unexpectedly | 11 | 2% | 1% |
| Deformation due to compressive stress | 7 | 1.3% | 0.1% |
| Failure to advance | 5 | 0.9% | 3.3% |
| Material separation | 5 | 0.9% | 0.1% |
| Premature activation | 5 | 0.9% | 0.2% |
| Torn material | 5 | 0.9% | 0.8% |
| Device markings/labelling problema problem with the device markings or label | 4 | 0.7% | 0.1% |
| Hole in material | 4 | 0.7% | 0% |
| Material split, cut or torn | 4 | 0.7% | 1% |
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 |
|---|---|---|
| No patient involvement | 100 | 18.5% |
| Edemaswelling from fluid | 8 | 1.5% |
| Capsular bag tear | 4 | 0.7% |
| Vitrectomy | 3 | 0.6% |
| Inflammationinflammation | 2 | 0.4% |
| Blurred vision | 1 | 0.2% |
| Endophthalmitisinfection inside the eye | 1 | 0.2% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.2% |
| Hypopyon | 1 | 0.2% |
| Injurya physical injury | 1 | 0.2% |
| Itching sensation | 1 | 0.2% |
| Painpain, site not specified | 1 | 0.2% |
| Tissue damage | 1 | 0.2% |
| Uveitis | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Platinum 1 Series | Product code KYB | All MAUDE reports |
|---|---|---|---|
| Reports | 540 | 8,704 | 26,136,888 |
| Share of that pool | — | 6.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 10.7% | 18.1% | 36.2% |
| Classified as malfunction | 89.3% | 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% |
| 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 | 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 Platinum 1 Series reports
How many FDA reports name Platinum 1 Series?
540 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 (89.3%) and injury (10.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
crack (19.1%), device contamination with chemical or other material (18.1%), break (14.6%), contamination (13.1%) and difficult or delayed positioning (8%). 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 Platinum 1 Series 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.