ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL— 510(k) K052703

Substantially Equivalent

Alden Optical Labs., Inc.

FDA 510(k) clearance K052703 for ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL, Substantially Equivalent on 2005-11-10. Applicant: Alden Optical Labs., Inc..

Clearance details

Applicant: Alden Optical Labs., Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2005-09-28
Decision date: 2005-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alden, NY, US

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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.