FDA recall Z-2289-2023

Johnson & Johnson Surgical Vision, Inc. · Class II · device

Product

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

International distribution to the countries of China, India, Korea.

Key facts

Status
Ongoing
Initiation date
2023-07-06
Report date
2023-08-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2289-2023