D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES— 510(k) K965052

Substantially Equivalent

Wesley Jessen Corp.

FDA 510(k) clearance K965052 for D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, Substantially Equivalent on 1997-05-14. Applicant: Wesley Jessen Corp..

Clearance details

Applicant: Wesley Jessen Corp.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1996-12-18
Decision date: 1997-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, 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.