Soft-55 Ew Aphakic, Vifilcon a(Soft Contacts for Extended Wear)

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Lenses, soft contact, extended wear

PMA Number

P960039 ↗

FDA Product Code

LPM

Device Class

Class III

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APWD Approval withdrawn

• Cvue Advanced (Hioxifilcon D) Soft (Hydrophilic) Contact Lens

  Class II

  FDA 510(k) K082393 Active Cleared 11 Sep 2008

• Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens

  Class II

  FDA 510(k) K960926 Active Cleared 10 Apr 1996

• Simulvue 38 (Polymacon) Soft (Hydrophilic) Bifocal Contact Lens

  Class II

  FDA 510(k) K942372 Active Cleared 7 Jul 1994

• Unilens 38 Soft Aspheric Contact Lens

  Class II

  FDA 510(k) K941836 Active Cleared 7 Jul 1994

• Seesoft (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens

  Class II

  FDA 510(k) K960380 Active Cleared 28 Mar 1996

• Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, Ll-38, Bayvue Aquaflex Mto, Unilens 38, Unisoft, Simulvue 38 Llbi 2,

  Class II

  FDA 510(k) K110452 Active Cleared 20 Apr 2011

See all devices from Unilens Corp., USA →