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FDA product code HQL · class 3 · Ophthalmic
Intraocular lens: medical device reports filed with FDA
79,755 reports carry this product code, 1992–2026; 30 brands with a page.
- 79,755
- reports with this product code
- 0.3% of all MAUDE reports
- 5,263
- reports, 12 months to August 2026
- 5,213 in the 12 months before
- 52.8%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code HQL is FDA's classification for "Intraocular lens" (ophthalmic panel), a class 3 device. 79,755 medical device reports carry this product code, 0.3% of the MAUDE database, from January 1992 to August 2026.
5,263 reports arrived in the 12 months to August 2026, close to the 5,213 of 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 (52.8%), injury (42.8%) and other (4.1%). 30 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 |
|---|---|---|
| Staar Surgical | 12,624 | 15.8% |
| Amo Puerto Rico Mfg | 9,240 | 11.6% |
| Bausch & Lomb | 8,616 | 10.8% |
| Alcon Research - Huntington | 8,136 | 10.2% |
| Abbott Medical Optics | 6,063 | 7.6% |
| Alcon Laboratories Ireland | 5,577 | 7% |
| Alcon Laboratories | 4,166 | 5.2% |
| Alcon Research / Huntington | 3,834 | 4.8% |
| Johnson & Johnson Surgical Vision | 3,473 | 4.4% |
| Alcon Research /Huntington | 2,217 | 2.8% |
| Rayner Intraocular Lenses | 1,983 | 2.5% |
| Hoya Surgical Optics | 1,846 | 2.3% |
| Alcon Laboratories /Huntington | 1,722 | 2.2% |
| Bausch + Lomb | 1,566 | 2% |
| Alcon Laboratories / Huntington | 1,291 | 1.6% |
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 |
|---|---|---|
| Breakthe device broke | 7,831 | 9.8% |
| Explanted | 5,805 | 7.3% |
| Lens (iol), torn, split, cracked | 3,723 | 4.7% |
| Device remains implanted | 3,456 | 4.3% |
| Lens replacement | 3,241 | 4.1% |
| Scratched material | 3,082 | 3.9% |
| Haptic(s), bent | 2,435 | 3.1% |
| Abnormal | 2,326 | 2.9% |
| Packaging problem | 2,303 | 2.9% |
| Leak/splashthe device leaked | 2,253 | 2.8% |
| Crackthe device cracked | 2,225 | 2.8% |
| Haptic(s), broken | 2,181 | 2.7% |
| Defective component | 2,063 | 2.6% |
| Insufficient device problem information | 1,860 | 2.3% |
| Other (for use when an appropriate device code cannot be identified) | 1,720 | 2.2% |
| Material split, cut or torn | 1,686 | 2.1% |
| Tears, rips, holes in device, device material | 1,670 | 2.1% |
| Defective devicethe device was defective | 1,509 | 1.9% |
| Replace | 1,378 | 1.7% |
| Lens, opacification of | 1,371 | 1.7% |
Questions about intraocular lens reports
What is product code HQL?
FDA's classification code for "Intraocular lens", class 3, reviewed by the ophthalmic panel. Every device report carries the product code of the device involved.
How many reports carry this code?
79,755 reports through August 2026, 5,263 of them in the latest 12 months.
Which brands appear most often?
Acrysof (9,149), Tecnis Simplicity (4,635), Tecnis Iol (2,808), Tecnis (2,746) and Tecnis Itec Preloaded 1-Piece Iol (2,431). 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.