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FDA (Device enforcement)Recalled 2018-07-03closedclass iii

Alden Optical: 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:

Is my product affected?

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 correction of refractive arnetro

  • UPC 00785811435660

Check against the official notice below — it lists the full affected range.

What happened

Alden Optical is recalling Zen RC Toric gas permeable contact lenses for daily wear distributed in the United States. The lenses came in 10-cc polycarbonate vials, with some vials labeled for specific prescriptions containing incorrect lenses instead. Four vials across lots B3225920, B3237210, B3237220, and B3237910 were affected, distributed in California, Georgia, Illinois, Maryland, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, and Utah.

The products involved are Zen RC TPC (Toric Peripheral Curve) and Zen RC FT (Front Toric Optics) contact lenses. The source document does not specify a remedy or what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Vials labeled for the prescriptions contained incorrect lenses

Details from the source

Reason for recall: Vials labeled for the prescriptions contained incorrect lenses Distribution: US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT. Quantity: 4 vials Lot/code info: B3225920 UDI-(01)00785811435660/(10)18101PTC008 B3237210 UDI-(01)00785811435660/(10)18101PTC008 B3237220 UDI-(01)00785811435660/(10)18101PTC008 B3237910 UDI-(01)00785811435660/(10)18101PTC008

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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