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FreshKon® 1-Day (Etafilcon A)

OCULUS PRIVATE LIMITED · Model Alluring Eye,Mosaic,Colors Fusion · UDI-DI 08886428047368

MVN LPL Prescription

510(k) clearances

372

Adverse events

Recalls

101

Facilities

Description

10 sterile one day disposable daily wear soft contact lenses, 42% etafilcon A, 58% water, immersed in 0.9% buffered saline. Indication for Use:The FreshKon® Contact Lens is indicated for daily wear to enhance the color and/or the size and/or the definition of the natural iris and/or for the correction of refractive ametropia (myopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 2.00 diopter (D) or less of astigmatism. It also helps protect against transmission of harmful UV radiation to the cornea and into the eye. The Eye Care Professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.

Recalls

Date	Firm	Reason
2025-08-22	CooperVision, Inc.	One lot manufactured with an invalid sterilization cycle.
2025-08-22	CooperVision, Inc.	One lot manufactured with an invalid sterilization cycle.
2025-08-22	CooperVision, Inc.	One lot manufactured with an invalid sterilization cycle.
2025-02-27	CooperVision, Inc.	a limited number of lots were manufactured with an incorrect cylinder power.
2024-03-20	Ontact Inc	Contact lenses recalled due to potential bacterial contamination.
2018-02-21	CooperVision Inc.	The secondary packaging is labeled with an incorrect expiration date.
2018-02-21	CooperVision Inc.	The secondary packaging is labeled with an incorrect expiration date.
2018-02-21	CooperVision Inc.	The secondary packaging is labeled with an incorrect expiration date.
2018-02-21	CooperVision Inc.	The secondary packaging is labeled with an incorrect expiration date.
2017-12-18	Johnson & Johnson Vision Care, Inc.	Package integrity failure observed during routine shift package integrity testing at an external re-packager.

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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.