Agency classClass IIIOur severity:Moderate FDA (Devices)·Z-2981-2018·Announced 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.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric indicates is typically a score of 1 or 2. The hazard involves a labeling error resulting in incorrect lenses, which is a moderate risk but not a Class I or II hazard with reported serious injuries.

Plain-English summary

Alden Optical is recalling 36 vials of Zenlens Toric-Gas Permeable Contact Lenses for Daily Wear. The recall was initiated because the vials were labeled for specific prescriptions but contained incorrect lenses. The affected products include various Zenlens Toric models, such as Front Toric, Toric Peripheral Curve, and combinations with Microvault.

The recalled lenses were distributed in the United States in the states of California, Georgia, Illinois, Maryland, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, and Utah. The specific lot numbers and UDI codes for the affected units are listed in the official recall documentation.

Consumers who have these specific vials should stop using the lenses immediately and contact their eye care professional or Alden Optical for instructions on how to return the product or obtain a replacement. The lenses are indicated for the correction of refractive anisometropia in non-diseased eyes, but the labeling error poses a risk of incorrect prescription use.

The recalled product

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 +…
Manufacturer: Alden Optical
Category: Medical Device — Contact Lenses
Hazard: mis-labeling
incorrect-product
Affected units: 36

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 2 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 2 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
High
Alden Optical Recalls HP59 Sphere Daily Wear Soft Contact Lenses
FDA (Devices) · 2018-03-21
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 · mis labeling