PMA supplement
P060011 S041: C-flex lntraocular Lens; C-flex Aspheric lntraocular Lens; 6.0 mm Aspheric lntraocular Lens; RayOne Aspheric; RayOne Sph
FDA PMA supplement · 30-Day Notice · Rayner Intraocular Lenses, Ltd.
Key facts
| Original PMA | P060011 |
|---|---|
| Supplement number | S041 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | C-flex lntraocular Lens; C-flex Aspheric lntraocular Lens; 6.0 mm Aspheric lntraocular Lens; RayOne Aspheric; RayOne Sph |
| Generic name | Intraocular lens |
| Applicant | Rayner Intraocular Lenses , Ltd. |
| Product code | HQL |
| Received date | May 14, 2025 |
| Decision date | Jun 12, 2025 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: