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FreshKon® (Methafilcon A)

OCULUS PRIVATE LIMITED · Model Alluring Eye, Mosaic,Colors Fusion · UDI-DI 08886428047382

LPL Prescription

510(k) clearances

4,868

Adverse events

Recalls

133

Facilities

Description

Two sterile daily wear soft contact lenses, 45% methafilcon A, 55% water, immersed in 0.9% buffered saline. Indication for use: The FreshKon® Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia) in aphakic or not‐aphakic persons with non‐diseased eyes. The lens may be disinfected using a chemical disinfection system. Eye Care Professionals may prescribe the lens for frequent replacement wear, with cleaning disinfection and scheduled replacement (see WEARING SCHEDULE) When prescribed for frequent replacement wear,the lens may be disinfected using a chemical disinfection system.

Recalls

Date	Firm	Reason
2025-09-30	Alcon Research LLC	Potential for a weak seal in some units resulting in compromise in sterility.
2025-06-12	Johnson & Johnson Vision Care, Inc.	Due to defects (bubbles/voids) identified during standard finished goods testing
2024-08-08	Alcon Research LLC	Material with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the entirety of their labeled shelf life,
2023-02-14	CooperVision, Inc.	The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.
2022-12-27	CooperVision, Inc.	Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
2021-05-19	CooperVision Inc.	Misaligned placement of an axis mark can cause the patient to experience blurred vision
2021-05-19	CooperVision Inc.	Misaligned placement of an axis mark can cause the patient to experience blurred vision
2021-05-19	CooperVision Inc.	Misaligned placement of an axis mark can cause the patient to experience blurred vision
2021-05-19	CooperVision Inc.	Misaligned placement of an axis mark can cause the patient to experience blurred vision
2021-05-19	CooperVision Inc.	Misaligned placement of an axis mark can cause the patient to experience blurred vision

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.