IOL INJECTOR SET— 510(k) K070669

Substantially Equivalent

Medicel AG

FDA 510(k) clearance K070669 for IOL INJECTOR SET, Substantially Equivalent on 2007-11-01. Applicant: Medicel AG.

Clearance details

Applicant: Medicel AG
Product code: Code KYB
Advisory panel: Ophthalmic
Date received: 2007-03-12
Decision date: 2007-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hasbrouck Heights, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KYB

product code KYB

Injury: 218
Malfunction: 1,989
Other: 1
Total: 2,208

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.