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Unicoeye; BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens

Shenzhen Dashicheng Optical Technology Co., Ltd. · Model BARBIE · UDI-DI 06975326567787

LPL MVN Prescription

510(k) clearances

4,868

Adverse events

Recalls

133

Facilities

Description

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available tinted and used to enhance or alter the apparent color of the eye. Disposable Wear: Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When prescribed for Daily Disposable Wear, the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.

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.