OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES)— 510(k) K983278

Substantially Equivalent

Alden Optical Labs., Inc.

FDA 510(k) clearance K983278 for OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES), Substantially Equivalent on 1998-11-25. Applicant: Alden Optical Labs., Inc..

Clearance details

Applicant: Alden Optical Labs., Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 1998-09-17
Decision date: 1998-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Junction, CO, US

Download summary PDF View on FDA.gov ↗

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.