FDA recall Z-0464-2019

Johnson & Johnson Surgical Vision Inc · Class II · device

Product

Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.

Reason for recall

Expired intraocular lenses were distributed.

Distribution

US Nationwide distribution in the states of IN, MN, NC, NV, TX, and WA, WV. There was no foreign/military/government distribution.

Key facts

Status
Terminated
Initiation date
2018-06-21
Report date
2018-11-21
Termination date
2021-04-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Ana, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0464-2019