AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P060022/S002 · decided 2009-02-18
Approval details
- PMA number
- P060022
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2008-10-24
- Decision date
- 2009-02-18
- Days to decision
- 117 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR CHANGES TO THE PACKAGING, LABELING AND DESIGN OF THE AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL: AKREOS ADVANCED OPTICS ASPHERIC INTRAOCULAR LENS, AO60. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AKREOS AO MICRO INCISION LENS, MODEL MI60L AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS IN THE VISUAL CORRECTION OF APHAKIA.
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 |
|---|---|---|
| Bausch + Lomb PreVue Inserter for enVista Preloaded (K192005) | Bausch & Lomb, Inc. | 2019-10-04 |
| Crystalsert Lens Delivery System (K173480) | Bausch & Lomb, Inc. | 2017-12-11 |
| Bausch + Lomb Injector System (K151102) | Bausch & Lomb, Inc. | 2015-05-22 |
| BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, (K131208) | Bausch & Lomb, Inc. | 2013-09-11 |
| BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI (K122575) | Bausch & Lomb, Inc. | 2012-12-20 |
| BAUSCH & LOMB IOL INJECTOR (K113852) | Bausch & Lomb, Inc. | 2012-09-28 |
| OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION (K112909) | Bausch & Lomb, Inc. | 2012-04-30 |
| EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION (K111877) | Bausch & Lomb, Inc. | 2012-01-24 |