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Miru 1day Menicon Flat Pack TC CP30

MENICON CO.,LTD. · Model +6.00/-1.25/180 · UDI-DI 00884465602012

LPL
10
510(k) clearances
4,868
Adverse events
70
Recalls
133
Facilities

Recalls

DateFirmReason
2025-09-30Alcon Research LLCPotential for a weak seal in some units resulting in compromise in sterility.
2025-06-12Johnson & Johnson Vision Care, Inc.Due to defects (bubbles/voids) identified during standard finished goods testing
2024-08-08Alcon Research LLCMaterial 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,
2023-02-14CooperVision, Inc.The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.
2022-12-27CooperVision, Inc.Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
2021-05-19CooperVision Inc.Misaligned placement of an axis mark can cause the patient to experience blurred vision
2021-05-19CooperVision Inc.Misaligned placement of an axis mark can cause the patient to experience blurred vision
2021-05-19CooperVision Inc.Misaligned placement of an axis mark can cause the patient to experience blurred vision
2021-05-19CooperVision Inc.Misaligned placement of an axis mark can cause the patient to experience blurred vision
2021-05-19CooperVision 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.