DURASOFT4 (Ofilcon A) Spherical Hydrophilic Lens

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

Generic Name

Lenses, soft contact, daily wear

PMA Number

P850072 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APWD Approval withdrawn

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• Modification to Karats Multi-Purpose Solution

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  FDA 510(k) K031957 Active Cleared 14 Aug 2003

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