FDA recall Z-0071-2018

Product

AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA. Used to fold and insert the firm's IOL's.

Reason for recall

The recommended storage temperature on the label is incorrect.

Distribution

Nationwide distribution including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2017-09-01

Report date

2017-11-15

Termination date

2018-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ontario, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0071-2018