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Miru 1day Menicon Flat Pack TC CP30
MENICON CO.,LTD. · Model -8.50/-1.25/165 · UDI-DI 00884465601596
10
510(k) clearances
4,868
Adverse events
70
Recalls
133
Facilities
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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Get your free API keyRead the docsData 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.
