FDA recall Z-0735-2024

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

Product

TECNIS Toric II OptiBlue IOL Models ZCW

Reason for recall

Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks.

Distribution

International distribution to the country of Japan.

Key facts

Status: Ongoing
Initiation date: 2023-12-12
Report date: 2024-01-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0735-2024