BAUSCH & LOMB PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
FDA premarket approval P980006/S008 · decided 2005-05-27
Approval details
- PMA number
- P980006
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BAUSCH & LOMB PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2005-04-25
- Decision date
- 2005-05-27
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR A MULTIFOCAL DESIGN OF THE BAUSCH & LOMB PUREVISION VISIBILITY TINTED CONTACT LENSES AND IS INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 30 DAYS BETWEEN REMOVALS, FOR CLEANING AND DISINFECTION OR DISPOSAL OF THE LENS, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENS IS INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA AND ASTIGMATISM) AND PRESBYOPIA IN APHAKIC AND/OR NOT-APHAKIC PERSONS WITH NON-DISEASED EYES, EXHIBITING ASTIGMATISM OF 2.00 DIOPTERS
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| 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 |