On Dec 31, 2007, the FDA received a filing from UNILENS CORPORATION USA for a 135 review track for 30-day notice of process change - manufacturer/sterilizer/packager/supplier. On Mar 03, 2008, the OP review committee issued the following statement with the approval order:
APPROVAL TO BEGIN PARAMETRIC RELEASE FOR HYDROPHILIC LENSES PACKAGED IN VIALS.
The review and decision took 63 days.
|Trade Name||SOFTCON EW 2 & SOFT-55 EW APHAKIC SOFT CONTACT LENSES|
|Generic Name||Lenses, soft contact, extended wear|
|Applicant||UNILENS CORPORATION USA|
|Contact||10431 72nd Street North|
Largo, FL, 33777
Jan 03, 2002
Location Change - Manufacturer/Sterilizer/Packager/Supplier (Normal 180 Day Track)
APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT UNILENS CORPORATION, USA, LARGO, FLORIDA.
Jul 09, 1998
Process Change - Manufacturer/Sterilizer/Packager/Supplier (30-Day Notice)
Requested that the device which is terminally sterilized by steam sterilization, be released into distribution using parametric criteria rather than the existing Biological Indicators.
Apr 17, 1997
APPROVAL FOR THE SOFT-55 EW APHAKIC (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR. THIS DEVICE IS INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN APHAKIC PERSONS (AFTER CATARACT SURGERY) THAT ARE MYOPIC OR HYPEROPIC. SOFT-55 EW APHAKIC LENSES MAY BE WORN BY PERSONS WHO MAY EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY