Clearance details

Applicant: CooperVision, Inc.
Product code: Code MVN
Device class: Class 2
Regulation: 21 CFR 886.5925
Advisory panel: Ophthalmic
Date received: 2006-07-10
Decision date: 2006-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norfolk, VA, US

Recent devices under product code MVN

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K261812 — HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens +2 more2026-07-07
K202448 — DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal2020-09-22
K202036 — Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal2020-08-21
K150630 — Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear2015-06-15
K143190 — Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens2015-01-16

More clearances from CooperVision, Inc.

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Adverse events under product code MVN

product code MVN

Injury: 149
Total: 149

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K061948

K-number listed on FDA's recall record

Z-0542-2014 — Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lensesClass II·Terminated·CooperVision Inc.·20131120

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061948.