enVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T)
FDA premarket approval P910056/S027 · decided 2018-06-08
Approval details
- PMA number
- P910056
- Supplement
- S027
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- enVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T)
- Generic name
- LENS, INTRAOCULAR, TORIC OPTICS
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2017-10-30
- Decision date
- 2018-06-08
- Days to decision
- 221 days
- Decision code
- APPR
- Product code
- MJP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for the enVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T). The device is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision.
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 |