510(k) K162597— Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc

Substantially Equivalent

Alcon Laboratories, Inc.

Clearance details

Applicant: Alcon Laboratories, Inc.
Product code: Code LPN
Advisory panel: Ophthalmic
Date received: 2016-09-19
Decision date: 2016-10-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Fort Worth, TX, US

Adverse events under product code LPN

product code LPN

Injury: 333
Other: 8
Total: 341

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.