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FDA product code KYB · class 1 · Ophthalmic
Lens, guide, intraocular: medical device reports filed with FDA
8,704 reports carry this product code, 1996–2026; 24 brands with a page.
- 8,704
- reports with this product code
- 0% of all MAUDE reports
- 346
- reports, 12 months to August 2026
- 422 in the 12 months before
- 81.5%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code KYB is FDA's classification for "Lens, guide, intraocular" (ophthalmic panel), a class 1 device. 8,704 medical device reports carry this product code, 0% of the MAUDE database, from January 1996 to August 2026.
346 reports arrived in the 12 months to August 2026, down 18% from 422 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 (81.5%), injury (18.1%) and other (0.3%). 24 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Alcon Research - Huntington | 2,210 | 25.4% |
| Staar Surgical | 1,575 | 18.1% |
| Alcon Laboratories /Huntington | 1,091 | 12.5% |
| Alcon Research - Alcon Precision Device | 897 | 10.3% |
| Alcon Laboratories / Huntington | 635 | 7.3% |
| Abbott Medical Optics | 545 | 6.3% |
| Alcon Laboratories | 503 | 5.8% |
| Johnson & Johnson Surgical Vision | 398 | 4.6% |
| Amo Puerto Rico Mfg | 259 | 3% |
| Bausch & Lomb | 194 | 2.2% |
| Alcon Research / Huntington | 91 | 1% |
| Alcon Research /Huntington | 53 | 0.6% |
| Advanced Medical Optics | 15 | 0.2% |
| Amo Manufacturing USA | 10 | 0.1% |
| Allergan | 5 | 0.1% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Sticking | 1,470 | 16.9% |
| Device damaged prior to usethe device was damaged before use | 659 | 7.6% |
| Device damaged by another device | 613 | 7% |
| Breakthe device broke | 578 | 6.6% |
| Crackthe device cracked | 456 | 5.2% |
| Lens (iol), torn, split, cracked | 429 | 4.9% |
| Failure to eject | 322 | 3.7% |
| Lens damaged in delivery system | 312 | 3.6% |
| Other (for use when an appropriate device code cannot be identified) | 291 | 3.3% |
| Failure to advance | 283 | 3.3% |
| Difficult to insertthe device was hard to insert | 269 | 3.1% |
| Scratched material | 263 | 3% |
| Defective devicethe device was defective | 260 | 3% |
| Haptic damaged in delivery system | 249 | 2.9% |
| Lens, damaged by cartridge | 220 | 2.5% |
| Material twisted/bent | 207 | 2.4% |
| Device contamination with chemical or other material | 197 | 2.3% |
| Tears, rips, holes in device, device material | 185 | 2.1% |
| Failure to deliverthe device did not deliver the dose or item | 179 | 2.1% |
| Defective component | 174 | 2% |
Questions about lens, guide, intraocular reports
What is product code KYB?
FDA's classification code for "Lens, guide, intraocular", class 1, reviewed by the ophthalmic panel. Every device report carries the product code of the device involved.
How many reports carry this code?
8,704 reports through August 2026, 346 of them in the latest 12 months.
Which brands appear most often?
Monarch Iol Delivery System - Cartridge (1,435), AcrySof IQ Singlepiece IOL with ULTRASERT Delivery System (1,413), Microstaar Injector (574), Platinum 1 Series (539) and AcrySof IQ Aspheric UV Absorbing IOLwith UltraSert Delivery System (522). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.