FDA.reportPublic FDA data

PMA N16895S087

Device
SOFLENS (POLYMACON) CONTACT LENSES
Applicant
Bausch & Lomb, Inc.
PMA number
N16895
Supplement
S087
Product code
LPM
Decision date
2001-03-26
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
APPROVAL FOR 1) THE ESTABLISHMENT OF SEPARATE LABELING FOR THE THERAPEUTIC USE INDICATION; AND, 2) COMBINING THE PACKAGE INSERT AND PROFESSIONAL FITTING GUIDE INTO A SINGLE REFERENCE INTENDED FOR THE EYE CARE PRACTITIONER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES SOFLENS(R) (POLYMACON) CONTACT LENSES (PLANO T) AND BAUSCH & LOMB OPTIMA(R) FW (POLYMACON) VISIBILITY TINTED CONTACT LENSES. THE LENSES ARE INDICATED FOR USE IN THE TREATMENT AND MANAGEMENT OF ACUTE AND CHRONIC CORNEAL PATHOLOGIES SUCH AS BULLOUS KERATOPATHY, CORNEAL ULCERS AND EROSION, DRY EYES, KERATITIS PROTECTION OF CORNEA DURING AND AFTER SURGERY, ACCIDENTAL OR SURGICAL TRAUMA, AND ENTROPION. WHEN PRESCRIBED FOR THERAPEUTIC USE, THE SOFLENS(R) (POLYMACON) CONTACT LENSES (PLANO T AND OPTIMA(R) FW) MAY BE WORN FOR DAILY OR EXTENDED WEARING PERIODS. THE EYE CARE PRACTITIONER SHOULD RECOMMEND EITHER SINGLE-USE DISPOSABLE WEAR OR A SCHEDULE OF PERIODIC REPLACEMENT, AND SHOULD PROVIDE INSTRUCTIONS FOR CLEANING, DISINFECTION, AND REPLACEMENT OF THE LENSES. THE LENSES MAY BE DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM. THE LENS SHOULD BE INSERTED AND REMOVED ONLY AS THE EYE CARE PRACTITIONER HAS INSTRUCTED.

Current openFDA PMA Record#

Device
SOFLENS (POLYMACON) CONTACT LENSES
Applicant
Bausch & Lomb, Inc.
PMA number
N16895
Supplement
S087
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2001-03-26
Decision code
APPR
Date received
1999-11-16
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR 1) THE ESTABLISHMENT OF SEPARATE LABELING FOR THE THERAPEUTIC USE INDICATION; AND, 2) COMBINING THE PACKAGE INSERT AND PROFESSIONAL FITTING GUIDE INTO A SINGLE REFERENCE INTENDED FOR THE EYE CARE PRACTITIONER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES SOFLENS(R) (POLYMACON) CONTACT LENSES (PLANO T) AND BAUSCH & LOMB OPTIMA(R) FW (POLYMACON) VISIBILITY TINTED CONTACT LENSES. THE LENSES ARE INDICATED FOR USE IN THE TREATMENT AND MANAGEMENT OF ACUTE AND CHRONIC CORNEAL PATHOLOGIES SUCH AS BULLOUS KERATOPATHY, CORNEAL ULCERS AND EROSION, DRY EYES, KERATITIS PROTECTION OF CORNEA DURING AND AFTER SURGERY, ACCIDENTAL OR SURGICAL TRAUMA, AND ENTROPION. WHEN PRESCRIBED FOR THERAPEUTIC USE, THE SOFLENS(R) (POLYMACON) CONTACT LENSES (PLANO T AND OPTIMA(R) FW) MAY BE WORN FOR DAILY OR EXTENDED WEARING PERIODS. THE EYE CARE PRACTITIONER SHOULD RECOMMEND EITHER SINGLE-USE DISPOSABLE WEAR OR A SCHEDULE OF PERIODIC REPLACEMENT, AND SHOULD PROVIDE INSTRUCTIONS FOR CLEANING, DISINFECTION, AND REPLACEMENT OF THE LENSES. THE LENSES MAY BE DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM. THE LENS SHOULD BE INSERTED AND REMOVED ONLY AS THE EYE CARE PRACTITIONER HAS INSTRUCTED.