FDA Enforcement
Class II
Terminated
TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.
Recall: Z-1163-2021
·
Reported March 10, 2021
Enforcement
- Recall Number
- Z-1163-2021
- Event ID
- 87320
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Johnson & Johnson Surgical Vision Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 10, 2021
- Initiation Date
- January 27, 2021
- Classification Date
- March 3, 2021
- Termination Date
- November 9, 2022
- Address
- 1700 E Saint Andrew Pl, Santa Ana, CA, 92705-4933, United States
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
Due to the release of nonconforming Intraocular Lenses (IOLs).
Code Info
Model Number: ZCT150 UDI/GTIN Codes: (01)05050474552210(17)221123(21)8144121847 5050474552210 Lot Number: 8144121847
Distribution
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.
Quantity
27 lenses