OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR— 510(k) K003996

Substantially Equivalent

Ocu-Ease Optical Products, Inc.

FDA 510(k) clearance K003996 for OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR, Substantially Equivalent on 2001-02-21. Applicant: Ocu-Ease Optical Products, Inc..

Clearance details

Applicant: Ocu-Ease Optical Products, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2000-12-26
Decision date: 2001-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pinole, CA, US

Download summary PDF View on FDA.gov ↗

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.