Z-2289-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 9, 2023
- Initiation Date
- July 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 61 units
Product Description
TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
Reason for Recall
Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
Distribution Pattern
International distribution to the countries of China, India, Korea.
Code Information
UDI-DI: N/A/ Serial Numbers: 8046642236, 8046652236, 8046662236, 8046672236, 8046682236, 8046692236, 8046702236, 8046712236, 8046722236, 8046732236, 8046742236, 8046752236, 8046762236, 8046772236, 8046782236, 8046792236, 8046802236, 8046812236, 8046822236, 8046832236, 8046842236, 8046852236, 8046862236, 8046872236, 8046882236, 8046892236, 8046902236, 8046912236, 8046922236, 8046932236, 8046942236, 8046952236, 8046962236, 8046972236, 8046982236, 8046992236, 8047002236, 8047012236, 8047022236, 8047032236, 8047042236, 8047052236, 8047062236, 8047072236, 8047082236, 8047102236, 8047112236, 8047122236, 8047132236, 8047142236, 8047152236, 8047162236, 8047172236, 8047182236, 8047192236, 8047202236, 8047212236, 8047222236, 8047232236, 8047242236, 8047252236