XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
FDA premarket approval P080021 · decided 2009-02-02
Approval details
- PMA number
- P080021
- Trade name
- XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb, Incorporated
- Date received
- 2008-08-07
- Decision date
- 2009-02-02
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL). MODEL X-60 AND MODEL X-70. THIS DEVICE IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM THE CATARACTOUS LENS HAS BEEN REMOVED BY AN EXTRACAPSULAR CATARACT EXTRACTION METHOD. THE LENS IS INTENDED FOR PLACEMENT IN THE CAPSULAR BAG.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| EyeGility™ Inserter for Preloaded enVista IOLs (K242389) | Bausch & Lomb, Incorporated | 2024-10-10 |
| Samfilcon B Custom Contact Lens (K230954) | Bausch + Lomb, Incorporated | 2023-11-17 |
| Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (K220613) | Bausch & Lomb, Incorporated | 2023-03-08 |
| Bausch + Lomb Preservative Free Lubricating and Rewetting Drops (K222541) | Bausch & Lomb, Incorporated | 2022-12-06 |
| Independent Corneal Viewing Chamber (IVC-21) (K211786) | Bausch + Lomb, Incorporated | 2021-12-03 |
| ABT12 multi-purpose solution (K202932) | Bausch & Lomb, Incorporated | 2021-05-28 |
| Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (K210975) | Bausch & Lomb, Incorporated | 2021-05-24 |
| Boston One Step Liquid Enzymatic Cleaner (K200416) | Bausch & Lomb, Incorporated | 2020-09-23 |