Aaren Scientific, Incorporated: Medical Device Recall in 2015 - (Recall #: Z-1309-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Aaren Scientifics EC-3 IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by phacoemulsification.

Product Classification:

Class II

Date Initiated: February 13, 2015

Date Posted: April 1, 2015

Recall Number: Z-1309-2015

Event ID: 70557

Reason for Recall:

Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements.

Status: Terminated

Product Quantity: 28 units

Code Information:

Serial No. 1181331102, 1181321102, 1393231208, 1117161211, 1180941102, 1031031102, 1190261307, 1190231307, 1190091307, 1190101307, 1190431307, 1190441307, 1276591307, 1305951307, 119071307, 1176951102, 1192921102, 1277111307, 1189541307, 1189551307, 1187761307, 1189531307, 1309911307, 1277101307, 1181331102, 1181321102, 1393231208, 1117161211, 1180941102, 1031031102, 1190261307, 1190231307, 1190091307, 1190101307, 1190431307, 1190441307, 1276591307, 1305951307, 1190071307, 1176951102, 1192921102, 1277111307, 1189541307, 1189551307, 1187761307, 1189531307, 1309911307, 1277101307, 1276941307, 1309961307.

Distribution Pattern:

Distributed in the states of OK, KS, FL, and AL.

Voluntary or Mandated:

Voluntary: Firm initiated