K974780

Substantially Equivalent

SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS

Applicant: Bausch & Lomb, Inc.
Product code: LPL
Advisory panel: Ophthalmic
Date received: 1997-12-22
Decision date: 1998-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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.