PMA P890012S004

Device: GENTLE TOUCH UV (NETRAFILCON) SOFT CONTACT LENSES
Applicant: Ciba Vision Corporation
PMA number: P890012
Supplement: S004
Product code: LPM
Decision date: 2000-09-12
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: APPROVAL FOR 1) A CHANGE IN MANUFACTURING METHOD FROM LATHE-CUT TO CAST-MOLDED; 2) A CHANGE IN HANDLING TINT FROM VAT DYES TO D & C GREEN #6; 3) TO ADD AN ULTRAVIOLET ABSORBER INTO NETRAFILCON A LENS MATERIAL; 4) AN ALTERNATE MANUFACTURING SITE AT WESLEY JESSEN PBH, LTD., SOUTHAMPTON, UNITED KINGDOM; 5) MODIFICATION TO THE INDICATINOS FOR USE INCLUDING THE SENTENCE "GENTLE TOUCH(TM) UV (NETRAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES HELP TO PROTECT AGAINST THE TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE"; AND 6) MODIFICATION OF THE NOTE AND WARNING IN LABELING.

Current openFDA PMA Record#

Device: GENTLE TOUCH UV (NETRAFILCON) SOFT CONTACT LENSES
Applicant: Ciba Vision Corporation
PMA number: P890012
Supplement: S004
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2000-09-12
Decision code: APPR
Date received: 1999-03-25
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR 1) A CHANGE IN MANUFACTURING METHOD FROM LATHE-CUT TO CAST-MOLDED; 2) A CHANGE IN HANDLING TINT FROM VAT DYES TO D & C GREEN #6; 3) TO ADD AN ULTRAVIOLET ABSORBER INTO NETRAFILCON A LENS MATERIAL; 4) AN ALTERNATE MANUFACTURING SITE AT WESLEY JESSEN PBH, LTD., SOUTHAMPTON, UNITED KINGDOM; 5) MODIFICATION TO THE INDICATINOS FOR USE INCLUDING THE SENTENCE "GENTLE TOUCH(TM) UV (NETRAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES HELP TO PROTECT AGAINST THE TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE"; AND 6) MODIFICATION OF THE NOTE AND WARNING IN LABELING.