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clear55A

CLEARLAB SG PTE. LTD. · Model clear55A · UDI-DI 08887861972712

LPL Prescription

510(k) clearances

4,882

Adverse events

Recalls

133

Facilities

Description

The clear55A Daily Wear Contact Lenses (methafilcon A) are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The clear55A Contact Lens is available in a single vision lens design. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55%). All lenses are tinted using the color additive Reactive Blue #19. The clear55A (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

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.