Home / Recalls / Alden Optical / Z-2981-2018

Z-2981-2018 Class III Terminated

Recalled by Alden Optical — Lancaster, NY

Recall Details

Product Type
Devices
Report Date
September 12, 2018
Initiation Date
July 3, 2018
Termination Date
February 28, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
36 vials

Product Description

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.

Reason for Recall

Vials labeled for the prescriptions contained incorrect lenses

Distribution Pattern

US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT.

Code Information

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

Other recalls by Alden Optical

  • Z-2982-2018 Class III — Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonat (July 3, 2018)
  • Z-0983-2018 Class II — Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 Prod (November 3, 2017)
  • Z-0986-2018 Class II — Alden HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59 Product Us (November 3, 2017)
  • Z-0982-2018 Class II — NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage (November 3, 2017)
  • Z-0987-2018 Class II — Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product Usa (November 3, 2017)
  • Z-0991-2018 Class II — ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 Prod (November 3, 2017)
  • Z-0984-2018 Class II — Alden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49 Produc (November 3, 2017)
  • Z-0989-2018 Class II — Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 Produ (November 3, 2017)
  • Z-0990-2018 Class II — Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product Usa (November 3, 2017)
  • Z-0981-2018 Class II — NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The (November 3, 2017)