ALCON SERIES 20000 LEGACY MACKOOL SYSTEM— 510(k) K955789

Substantially Equivalent

Alcon Laboratories

FDA 510(k) clearance K955789 for ALCON SERIES 20000 LEGACY MACKOOL SYSTEM, Substantially Equivalent on 1996-03-21. Applicant: Alcon Laboratories.

Clearance details

Applicant: Alcon Laboratories
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 1995-12-22
Decision date: 1996-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

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Adverse events under product code HQC

product code HQC

Injury: 2,378
Malfunction: 8,768
Total: 11,146

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.