FDA product code HQL: Intraocular Lens
HQL is the FDA product code for intraocular lens. It is a Class III device, regulated under 21 CFR 886.3600 and reviewed by the Ophthalmic panel. FDA has cleared 5 510(k) submissions under HQL, from 5 different applicants. The average 510(k) review took 105 days (median 104). 68 PMA applications cite this product code. FDA has posted 75 recalls for HQL devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Intraocular Lens |
| Device class | Class III |
| Regulation | 21 CFR 886.3600 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | PMA |
| Implant | Yes |
Compare with all 510(k) review times · Search every HQL clearance
Top HQL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Chiron Ophthalmics | 1 | 1992-01-27 |
| Staar Surgical Co. | 1 | 1991-12-18 |
| Nidek, Inc. | 1 | 1984-10-05 |
| American Medical Optics | 1 | 1984-10-01 |
| California Intraocular Lens | 1 | 1978-01-26 |
Most recent HQL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K914311 | Chiron Ophthalmics | CHIROFLEX II LENS MICROSERT(TM) | 1992-01-27 | 123 |
| K913626 | Staar Surgical Co. | SOFTRANS INJECTOR | 1991-12-18 | 125 |
| K842892 | Nidek, Inc. | NIDEK DIGITAL KERATOMETER | 1984-10-05 | 74 |
| K842504 | American Medical Optics | AMER. MEDICAL OPTICS DIGITAL KERATO- | 1984-10-01 | 97 |
| K771933 | California Intraocular Lens | CILCO ANTERIOR CHAMBER LENS | 1978-01-26 | 104 |
Recalls for HQL devices
75 product recalls in 39 recall events; 6 initiated in the last five years and 5 still open. Most recent: 2026-02-19.
| Year | Recalls |
|---|---|
| 2018 | 4 |
| 2020 | 2 |
| 2022 | 2 |
| 2023 | 1 |
| 2025 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code HQL?
HQL is the FDA product code for intraocular lens. It is a Class III device, regulated under 21 CFR 886.3600 and reviewed by the Ophthalmic panel.
What device class is HQL?
Class III, regulation 21 CFR 886.3600. Typical premarket route: PMA.
How long does a 510(k) take for product code HQL?
Across 5 cleared submissions the average was 105 days from receipt to decision (median 104).
Which companies have the most HQL clearances?
Chiron Ophthalmics (1); Staar Surgical Co. (1); Nidek, Inc. (1); American Medical Optics (1); California Intraocular Lens (1).
Have HQL devices been recalled?
Yes: 75 product recalls across 39 recall events; the most recent began 2026-02-19.
Next steps
- Run an FDA pathway report with predicate devices for product code HQL
- Run a recall and safety report across every HQL manufacturer
- Watch product code HQL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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