MONARCH IOL DELIVERY SYSTEM— 510(k) K981571

Substantially Equivalent

Alcon Laboratories

FDA 510(k) clearance K981571 for MONARCH IOL DELIVERY SYSTEM, Substantially Equivalent on 1998-07-09. Applicant: Alcon Laboratories.

Clearance details

Applicant: Alcon Laboratories
Product code: Code KYB
Advisory panel: Ophthalmic
Date received: 1998-05-04
Decision date: 1998-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

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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.