FDA recall Z-1163-2021

Johnson & Johnson Surgical Vision Inc · Class II · 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.

Reason for recall

Due to the release of nonconforming Intraocular Lenses (IOLs).

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.

Key facts

Status
Terminated
Initiation date
2021-01-27
Report date
2021-03-10
Termination date
2022-11-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Ana, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1163-2021