Alden Optical

Complete recall history across all FDA and CPSC categories — 13 total recalls

Alden Optical appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (13)

FDA medical device enforcement actions by Alden Optical

Date Product Reason Class
Jul 3, 2018 Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbo... Vials labeled for the prescriptions contained incorrect lenses Class III
Jul 3, 2018 Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarb... Vials labeled for the prescriptions contained incorrect lenses Class III
Nov 3, 2017 ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 P... Contact lenses lack sterility assurance. Class II
Nov 3, 2017 Alden HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59 Product... Contact lenses lack sterility assurance. Class II
Nov 3, 2017 Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 Product... Contact lenses lack sterility assurance. Class II
Nov 3, 2017 Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54 Product ... Contact lenses lack sterility assurance. Class II
Nov 3, 2017 Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 Pr... Contact lenses lack sterility assurance. Class II
Nov 3, 2017 Alden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49 Pro... Contact lenses lack sterility assurance. Class II
Nov 3, 2017 Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product ... Contact lenses lack sterility assurance. Class II
Nov 3, 2017 Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product ... Contact lenses lack sterility assurance. Class II
Nov 3, 2017 NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: ... Contact lenses lack sterility assurance. Class II
Nov 3, 2017 Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 P... Contact lenses lack sterility assurance. Class II
Nov 3, 2017 NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Us... Contact lenses lack sterility assurance. Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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