CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A)— 510(k) K111267

Substantially Equivalent

Abbconcise Optical Group, LLC

FDA 510(k) clearance K111267 for CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A), Substantially Equivalent on 2011-11-08. Applicant: Abbconcise Optical Group, LLC.

Clearance details

Applicant: Abbconcise Optical Group, LLC
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2011-05-04
Decision date: 2011-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Junction, CO, 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.