POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS)— 510(k) K004049

Substantially Equivalent

Optech, Inc.

FDA 510(k) clearance K004049 for POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS), Substantially Equivalent on 2001-05-23. Applicant: Optech, Inc..

Clearance details

Applicant: Optech, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2000-12-29
Decision date: 2001-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Junction, CO, US

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Adverse events under product code LPL

product code LPL

Injury: 988
Other: 4
Total: 992

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.