Z-1163-2021 Class II Terminated
FDA device recall Z-1163-2021 was initiated by Johnson & Johnson Surgical Vision Inc on January 27, 2021 and is designated Class II. Reason for recall: Due to the release of nonconforming Intraocular Lenses (IOLs). The recall status is terminated (terminated November 9, 2022). Affected quantity: 27 lenses.
Recall Details
- Product Type
- Devices
- Report Date
- March 10, 2021
- Initiation Date
- January 27, 2021
- Termination Date
- November 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 lenses
Product Description
TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.
Reason for Recall
Due to the release of nonconforming Intraocular Lenses (IOLs).
Distribution Pattern
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.
Code Information
Model Number: ZCT150 UDI/GTIN Codes: (01)05050474552210(17)221123(21)8144121847 5050474552210 Lot Number: 8144121847