PMA P830037S041

Device: DURASOFT 3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILLIC) CONTACT LENSES
Applicant: Alcon Laboratories, Inc.
PMA number: P830037
Supplement: S041
Product code: LPM
Decision date: 1999-05-20
Generic name: Lenses, soft contact, extended wear
Approval order statement: Approval for the DuraSoft(R) 3 UV (phemfilcon A) Spherical and Optifit Toric Clear, Handling Tint, Colors, and Color Complements Soft (hydrophilic) Contact Lens (lathe cut) for Extended Wear to incorporate the pigment carbazole violet as a handling tint at Wesley Jessen - Cidra Operation, Road 173, KM 1.1, Cidra, PR 00739. The pigment will be incorporated as an in-monomer tint by entrapment.

Current openFDA PMA Record#

Device: DURASOFT 3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILLIC) CONTACT LENSES
Applicant: Alcon Laboratories, Inc.
PMA number: P830037
Supplement: S041
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 1999-05-20
Decision code: APPR
Date received: 1998-07-06
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the DuraSoft(R) 3 UV (phemfilcon A) Spherical and Optifit Toric Clear, Handling Tint, Colors, and Color Complements Soft (hydrophilic) Contact Lens (lathe cut) for Extended Wear to incorporate the pigment carbazole violet as a handling tint at Wesley Jessen - Cidra Operation, Road 173, KM 1.1, Cidra, PR 00739. The pigment will be incorporated as an in-monomer tint by entrapment.