Agency classClass IIOur severity:High FDA (Devices)·Z-0987-2018·Announced 2018-03-21

Alden HP49 Toric Contact Lenses Recalled for Sterility Assurance Issues

Alden Optical is recalling 56 units of Alden HP49 Toric Daily Wear Soft contact lenses because they lack sterility assurance. The lenses were distributed in 25 US states and Canada.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a lack of sterility assurance in contact lenses, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Alden Optical is recalling 56 units of Alden HP49 Toric Daily Wear Soft contact lenses (Catalog Number: AOHPT49). The recall was initiated because the contact lenses lack sterility assurance. The product is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia and/or refractive astigmatism not exceeding 10 Diopters.

The affected units were distributed worldwide, specifically in the United States (California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Wisconsin, Wyoming) and Canada. The recall number is Z-0987-2018.

Consumers who have these contact lenses should stop using them immediately and contact their eye care professional or Alden Optical for further instructions. The specific lot codes associated with this recall include AZ150010, AZ150020, AZ126720, AZ153710, AZ153720, AZ136110, AZ146910, AZ146920, AZ143710, AZ143720, AZ146610, AZ146620, AZ156210, AZ156220, AZ151510, AZ155210, AZ138410, AZ138420, AZ154810, AZ154620, AZ162310, AZ162320, AZ159810, AZ159820, AZ145220, and AZ151120.

The recalled product

Product: Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia)…
Manufacturer: Alden Optical
Category: Medical Device — Contact Lenses
Hazard: lack-of-sterility
Affected units: 56

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

Part of a larger recall action

This product is one of 11 recalled by Alden Optical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

Same manufacturer · Alden Optical

See all →

Moderate
Alden Optical Recalls Zen RC Toric Contact Lenses with Incorrect Contents
FDA (Devices) · 2018-09-12
Moderate
Alden Optical Recalls Zenlens Toric Contact Lenses Due to Labeling Errors
FDA (Devices) · 2018-09-12
Severe
Alden Optical Recalls Contact Lenses Lacking Sterility Assurance
FDA (Devices) · 2018-03-21
Severe
Alden Optical Recalls ASTERA Multifocal Toric Contact Lenses for Sterility Issues
FDA (Devices) · 2018-03-21
Severe
Alden Optical Recalls NovaKone Daily Wear Soft Contact Lenses
FDA (Devices) · 2018-03-21

Same hazard · lack of sterility