Device product
TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.
Z-1163-2021
Product summary
- Event
- Event 87320
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27 lenses
- Official record key
device-enforcement:Z-1163-2021
Official wording
Reason: Due to the release of nonconforming Intraocular Lenses (IOLs).
Code information: Model Number: ZCT150 UDI/GTIN Codes: (01)05050474552210(17)221123(21)8144121847 5050474552210 Lot Number: 8144121847
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.
Derived failure modes
-
Unknown
Due to the release of nonconforming Intraocular Lenses (IOLs).