| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
| |
| Device | AcrySof Single-Piece IOL (SA60AT); AcrySof IQ Aspheric IOL (SN60WF); AcrySof Aspheric UV-Absorbing IOL (SA60WF); AcrySof |
|---|
| Generic Name | intraocular lens |
|---|
| Regulation Number | 886.3600 |
|---|
| Applicant | Alcon Laboratories, Inc.
6201 S. Fwy. Dr.
Fort Worth, TX 76134 |
|---|
| PMA Number | P930014 |
|---|
| Supplement Number | S161 |
|---|
| Date Received | 01/30/2026 |
|---|
| Decision Date | 04/30/2026 |
|---|
| Product Code |
HQL |
| Advisory Committee |
Ophthalmic |
|---|
| Supplement Type | Normal 180 Day Track |
|---|
| Supplement Reason | Change Design/Components/Specifications/Material |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
| Predetermined Change Control Plan Authorized | No |
|---|
Approval Order Statement
approval application (PMA) 180-day supplement, which requested approval for a new packaging configuration, automation of the primary and secondary packaging processes, and updates to shelf-life and storage conditions of the AcrySof IOLs (storage condition temperatures from 45 °C to 30 °C), and Clareon IOLs (to extend the shelf life from four (4) years to five (5) years at the temperature of 30 °C) in Alcon’s manufacturing facilities in West Virginia, USA and Cork, Ireland. |
|
|
