FDA product code QCB: Phakic Toric Intraocular Lens
QCB is the FDA product code for phakic toric intraocular lens. It is a Class III device, regulated under 21 CFR 886.3600 and reviewed by the Ophthalmic panel. Devices under QCB reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 5 recalls for QCB devices, 5 initiated in the last five years.
Definition
Intended to be implanted within the eye to optically correct astigmatism (with or without other refractive errors), without removing the natural crystalline lens.
Classification
| Field | Value |
|---|---|
| Device name | Phakic Toric Intraocular Lens |
| Device class | Class III |
| Regulation | 21 CFR 886.3600 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | PMA |
| Implant | Yes |
Recalls for QCB devices
5 product recalls in 2 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2026-01-21.
| Year | Recalls |
|---|---|
| 2023 | 4 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code QCB?
QCB is the FDA product code for phakic toric intraocular lens. It is a Class III device, regulated under 21 CFR 886.3600 and reviewed by the Ophthalmic panel.
What device class is QCB?
Class III, regulation 21 CFR 886.3600. Typical premarket route: PMA.
Have QCB devices been recalled?
Yes: 5 product recalls across 2 recall events; the most recent began 2026-01-21.
Next steps
- Run an FDA pathway report with predicate devices for product code QCB
- Run a recall and safety report across every QCB manufacturer
- Watch product code QCB 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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