Manufacturer

Alden Optical

13 recalls in our database name Alden Optical as the manufacturing or recalling firm.

What the numbers show

Total: 13
Critical: 0
Severe: 5
Most recent: 2018-09-12

Of the 13 recalls from Alden Optical we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (38%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–13 of 13

ModerateFDA (Devices)·Z-2982-2018·2018-09-12
Alden Optical Recalls Zen RC Toric Contact Lenses with Incorrect Contents
Alden Optical is recalling Zen RC Toric contact lenses because vials labeled for specific prescriptions contained incorrect lenses.
Product
Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC TPC (Toric Peripheral Curve) Zen RC FT (Front Toric Optics) Catalog Number: AOZNT Zenlens Toric - Zenlens contact lenses are indicated for daily wear for the corr
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-2981-2018·2018-09-12
Alden Optical Recalls Zenlens Toric Contact Lenses Due to Labeling Errors
Alden Optical is recalling 36 vials of Zenlens Toric-Gas Permeable Contact Lenses because the vials contained incorrect lenses for the prescriptions labeled on them.
Product
Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric); Zenlens Toric-Zenlens FT + MV (Front Toric+Microvault); Zenlens TPC-(Toric Peripheral Curve); Zenlens TPC + FT- (Toric Peripheral Curve + FrontTor
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-0991-2018·2018-03-21
Alden Optical Recalls ASTERA Multifocal Toric Contact Lenses for Sterility Issues
Alden Optical is recalling ASTERA Multifocal Toric Daily Wear Soft contact lenses because they lack sterility assurance. The recall affects units distributed in the US and Canada.
Product
ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 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 hyperopi
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0984-2018·2018-03-21
Alden Optical Recalls HP49 Sphere Daily Wear Soft Contact Lenses
Alden Optical is recalling 23 units of HP49 Sphere Daily Wear Soft contact lenses because they lack sterility assurance.
Product
Alden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49 Product Usage: The ALDEN SPHERE 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
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0985-2018·2018-03-21
Alden Optical Recalls Contact Lenses Lacking Sterility Assurance
Alden Optical is recalling specific daily wear soft contact lenses because they lack sterility assurance. Consumers should stop using the affected lenses.
Product
Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 Product Usage: The ALDEN SPHERE 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). T
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0981-2018·2018-03-21
Alden Optical Recalls NovaKone Daily Wear Soft Contact Lenses
Alden Optical is recalling NovaKone Daily Wear Soft contact lenses because they lack sterility assurance. The recall covers units distributed in the US and Canada.
Product
NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) in aphakic and not aphakic persons with
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0990-2018·2018-03-21
Alden HP59 Toric Contact Lenses Recalled for Lack of Sterility Assurance
Alden Optical is recalling HP59 Toric Daily Wear Soft contact lenses because they lack sterility assurance. Consumers should stop using the affected lenses.
Product
Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 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) and/
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0989-2018·2018-03-21
Alden Classic 55 Toric Contact Lenses Recalled for Sterility Issues
Alden Optical is recalling Alden Classic 55 Toric Daily Wear Soft contact lenses because they lack sterility assurance. The recall affects units distributed in the US and Canada.
Product
Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0986-2018·2018-03-21
Alden Optical Recalls HP59 Sphere Daily Wear Soft Contact Lenses
Alden Optical is recalling HP59 Sphere Daily Wear Soft contact lenses because they lack sterility assurance. The recall affects units distributed in the US and Canada.
Product
Alden HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59 Product Usage: The ALDEN SPHERE 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). T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0982-2018·2018-03-21
Alden Optical Recalls NovaKone Toric Contact Lenses for Sterility Issues
Alden Optical is recalling 33 units of NovaKone Toric Daily Wear Soft contact lenses because they lack sterility assurance. The lenses were distributed in 25 US states and Canada.
Product
NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The NOVAKONE TORIC lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not ap
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0988-2018·2018-03-21
Alden HP54 Toric Contact Lenses Recalled for Sterility Assurance Issues
Alden Optical is recalling HP54 Toric Daily Wear Soft contact lenses because they lack sterility assurance. Consumers should stop using the affected lenses.
Product
Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54 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) and/
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0987-2018·2018-03-21
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.
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) and/
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0983-2018·2018-03-21
Alden Classic 38 Sphere Daily Wear Soft Contact Lenses Recalled for Sterility Issues
Alden Optical is recalling Alden Classic 38 Sphere Daily Wear Soft contact lenses because they lack sterility assurance. The recall covers units distributed in the United States and Canada.
Product
Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 Product Usage: The ALDEN SPHERE 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 hyperop
Category
Medical Device
Distribution
Distributed nationwide