Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | SOFLENS (POLYMACON) CONTACT LENSES |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | Bausch & Lomb, Inc. 1400 NORTH GOODMAN ST. ROCHESTER, NY 14609-3547 |
PMA Number | N16895 |
Supplement Number | S084 |
Date Received | 10/01/1996 |
Decision Date | 01/30/1997 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING MODIFICTIONS TO SOFLENS(R) (POLYMACON) CONTACT LENSES INCLUDING THE FOLLOWING LENS TYPES (SERIES): 03, 04, OCCASIONS(TM) MULTIFOCAL, OPTIMA(TM) 38, OPTIMA(TM) 38/SP, U3, U4, SOFSPIN(TM), H03, H04, B3, B4, P.A.1, F3, H3, H4, N, NATURALTINE, OPTIMA(TM) FW, AND SEEQUENCE(TM). MODIFICATIONS INCLUDE: 1)REMOVING THE REPLACEMENT SYSTEM DESCRIPTORS FROM LABELING SPECIFIC TO THE OPTIMA(TM) FW CONTACT LENSES; 2)ADDING MONOVISIO FITTING TECHNIQUE FOR ALL BAUSCH & LOMB SOFLENS(R) (POLYMACON) CONTACT LENSES IN THIS SUPPLEMENT;3)CONSOLIDATING INFO IN SIX FITTING GUIDES INTO 3 FITTING GUIDES FOR SOFLENS(R), NATURALTINT(R), OCCASIONS(TM) MULTIFOCAL, AND P.A.1 CONTACT LENSES; 4)CONSOLIDATING 2 PATIENT INFO BOOKLETS (1 FOR FREQUENT REPLACEMENT USE AND 1 FOR DISPOSABLE USE) FOR SEEQUENCE(TM) (POLYMACON) VISIBILITY TINTED CONTACT LENSES INTO A SINGLE PATIENT INFO BOOKLET (THIS MODIFICATION RESULTS IN DELETION OF THE DISPOSABLE WEAR INDICATION); 5)FORMATTING CHANGES TO PACKAGE INSERTS, FITTING FUIDES & PATIENT INFO BOOKLETS TO BRING LABELING UP-TO-DATE WITH RECOMMENDATIONS IN CDRH'S CURRENT LABELING GUIDANCE; AND 6)SEPARATING THE THERAPEUTIC INDIATION FROM THE COSMETIC LABELING INCLUDED IN THIS SUPPLEMENT. |
|
|