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Qualis

Unicon Optical Co., Ltd. · Model +5.75 · UDI-DI 04719881883751

MVNLPL
10
510(k) clearances
372
Adverse events
16
Recalls
101
Facilities

Description

HDK Daily Contact Lens_5pk

Recalls

DateFirmReason
2025-08-22CooperVision, Inc.One lot manufactured with an invalid sterilization cycle.
2025-08-22CooperVision, Inc.One lot manufactured with an invalid sterilization cycle.
2025-08-22CooperVision, Inc.One lot manufactured with an invalid sterilization cycle.
2025-02-27CooperVision, Inc.a limited number of lots were manufactured with an incorrect cylinder power.
2024-03-20Ontact IncContact lenses recalled due to potential bacterial contamination.
2018-02-21CooperVision Inc.The secondary packaging is labeled with an incorrect expiration date.
2018-02-21CooperVision Inc.The secondary packaging is labeled with an incorrect expiration date.
2018-02-21CooperVision Inc.The secondary packaging is labeled with an incorrect expiration date.
2018-02-21CooperVision Inc.The secondary packaging is labeled with an incorrect expiration date.
2017-12-18Johnson & Johnson Vision Care, Inc.Package integrity failure observed during routine shift package integrity testing at an external re-packager.

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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.