Approval for the clareon™and clareon™ toric aspheric hydrophobic acrylic intraocular lens (iol). Clareon aspheric hydrophobic acrylic intraocular lens (iol):the clareon™ aspheric hydrophobic acrylic intraocular lens (iol) is indicated for primary implantation in the capsular bag in the posterior chamber of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Clareon toric aspheric hydrophobic acrylic intraocular lens (iol):the clareon™ toric aspheric hydrophobic acrylic intraocular lenses (iols) are indicated for primary implantation in the capsular bag in the posterior chamber of the eye for visual correction of aphakia and pre-existing corneal astigmatism to reduce residual refractive cylinder and improve uncorrected distance vision in adult patients in whom a cataractous lens has been removed. Clareon aspheric hydrophobic acrylic intraocular lens (iol) with the autonome pre-loaded delivery system:the clareon™ aspheric hydrophobic acrylic intraocular lens (iol) is indicated for primary implantation in the capsular bag in the posterior chamber of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Clareon toric aspheric hydrophobic acrylic intraocular lens (iol) with the autonome pre-loaded delivery system:the clareon™ toric aspheric hydrophobic acrylic intraocular lenses (iols) are indicated for primary implantation in the capsular bag in the posterior chamber of the eye for visual correction of aphakia and pre-existing corneal astigmatism to reduce residual refractive cylinder and improve uncorrected distance vision in adult patients in whom a cataractous lens has been removed.
| Device | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | Alcon Research, Ltd. |
| Date Received | 2019-07-11 |
| Decision Date | 2020-01-07 |
| PMA | P190018 |
| Supplement | S |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Alcon Research, Ltd. 6201 South Freeway, Tc-467 forth Worth, TX 76134 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190018 | Original Filing | |
| S021 | 2022-11-22 | 30-day Notice |
| S020 | 2022-04-22 | 30-day Notice |
| S019 | 2022-04-06 | 30-day Notice |
| S018 | ||
| S017 | 2021-12-02 | 30-day Notice |
| S016 | 2021-11-30 | 30-day Notice |
| S015 | 2021-11-23 | 30-day Notice |
| S014 | 2021-11-05 | 30-day Notice |
| S013 | ||
| S012 | ||
| S011 | 2021-03-26 | 30-day Notice |
| S010 | 2021-02-22 | Normal 180 Day Track No User Fee |
| S009 | 2020-12-14 | Real-time Process |
| S008 | 2020-10-30 | 30-day Notice |
| S007 | 2020-10-16 | 30-day Notice |
| S006 | 2020-08-31 | 30-day Notice |
| S005 | ||
| S004 | 2020-05-19 | 30-day Notice |
| S003 | ||
| S002 | ||
| S001 |