FDAFDA · Food and drugs·Recall number Z-1163-2021
TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.
Published March 10, 2021 · Recall initiated: January 27, 2021
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
Due to the release of nonconforming Intraocular Lenses (IOLs).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Johnson & Johnson Surgical Vision Inc
- Distributor
- U.S. Nationwide distribution in the states of AL, AZ, CA, FL, GA, IL, LA, MI, MN, NC, NY, OH, PA, SC, TN, TX, UT and WA.
- Lot
- Model Number: ZCT150 UDI/GTIN Codes: (01)05050474552210(17)221123(21)8144121847 5050474552210 Lot Number: 8144121847
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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