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clear58

CLEARLAB SG PTE. LTD. · Model clear58 · UDI-DI 08887861972699

LPL Prescription

510(k) clearances

4,868

Adverse events

Recalls

133

Facilities

Description

The clear58 (etafilcon A) Soft (hydrophilic) Contact Lens is available as a single vision spherical lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The ionic lens material, (etafilcon A) is a co-polymer of 2- hydroxyethyl methacrylate and methacrylic acid cross-linked with 1 ,l ,l - trimethylol propane trimethacrylate and ethylene glycol demethacrylate. It consists of 42% etafilcon A and 58% water by weight when immersed in buffered saline solution. The lens polymer contains a UV absorbing compound and is available clear or with a blue visibility-handling tint, color additive 'Reactive Blue 19', 2 1 CFR part 73.3 12 1. The (etafilcon A) name has been adopted by the United States Adopted Names Council (USAN).

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.