PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS— 510(k) K061948

Substantially Equivalent

CooperVision, Inc.

FDA 510(k) clearance K061948 for PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS, Substantially Equivalent on 2006-11-22. Applicant: CooperVision, Inc..

Clearance details

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

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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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.