FDAFDA · Food and drugs·Recall number Z-2981-2018
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 + FrontToric) Zenlens TPC + MV- (Toric Peripheral Curve+Microvault). Catalog Number: AOZNT Zenlens Toric - Zenlens contact lenses are indicated for daily wear for the correction of refractive arnetropia (myopia, hyperopia, and astigmatism) in aphakic and nonaphakic persons with non-diseased eyes.
Published September 12, 2018 · Recall initiated: July 3, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Vials labeled for the prescriptions contained incorrect lenses
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Alden Optical
- Distributor
- US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT.
- Lot
- Lot Number/ Serial Number B3235820 UDI- (01)00785811435660/(10)18101PTC008 B3237820 UDI- (01)00785811435660/(10)18101PTC008 B3240210 UDI-(01)00785811435660/(10)18101PTC008 B3235420 UDI-(01)00785811435660/(10)18101PTC008 B3238610 UDI-(01)00785811435660/(10)18101PTC008 B3238620 UDI-(01)00785811435660/(10)18111PTC001 B3239510 UDI-(01)00785811435660/(10)18101PTC008 B3239520 UDI-(01)00785811435660/(10)18111PTC001 B3238210 UDI-(01)00785811435660/(10)18101PTC008 B3238220 UDI-(01)00785811435660/(10)18101PTC008 B3240510 UDI-(01)00785811435660/(10)18101PTC008 B3240520 UDI-(01)00785811435660/(10)18101PTC008 B3240720 UDI-(01)00785811435660/(10)18101PTC008 B3238510 UDI-(01)00785811435660/(10)18101PTC008 B3238710 UDI-(01)00785811435660/(10)18101PTC008 B3239620 UDI-(01)00785811435677/(10)18116PTC004 B3238120 UDI-(01)00865576000218/(10)P004732 B3225210 UDI-(01)00785811435660/(10)18101PTC008 B3225410 UDI-(01)00785811435660/(10)18101PTC008 B3225420 UDI-(01)00785811435660/(10)18101PTC008 B3239910 UDI-(01)00865576000201/(10)N003062 B3239920 UDI-(01)00865576000201/(10)N003062 B3236610 UDI-(01)00785811435660/(10)18101PTC008 B3240320 UDI-(01)00785811435660/(10)18101PTC008 B3238410 UDI-(01)00785811435660/(10)18101PTC008 B3238810 UDI-(01)00785811435677/(10)18116PTC004 B3238820 UDI-(01)00785811435677/(10)18116PTC004 B3235620 UDI-(01)00785811435660/(10)18101PTC008 B3240410 UDI-(01)00785811435660/(10)18101PTC008 B3240420 UDI-(01)00785811435660/(10)18101PTC008 B3235220 UDI-(01)00785811435660/(10)18101PTC008 B3237010 UDI-(01)00785811435677/(10)18116PTC004 B3237020 UDI-(01)00785811435677/(10)18116PTC004 B3236110 UDI-(01)00785811435660/(10)18101PTC008 B3236010 UDI-(01)00785811435660/(10)18101PTC008
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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