The Recall Desk
ModerateFDA (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.

What this means for you

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 + FrontTor
Manufacturer
Alden Optical
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 →