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Terminated

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.

FDA Recall Z-1309-2015 · Posted 2015-03-20

Recalling FirmAaren Scientific, Incorporated
Recall StatusTerminated
Product CodeHQL
Date Initiated2015-02-13
Date Terminated2015-06-29
Product Quantity28 units

Reason for Recall

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

Firm Action

A customer notification letter dated 2/13/15 was sent to all customers who received the Intraocular Lens model EC-3 PAL. The letter provides the customers with the problems identified and the actions to be taken. Customers are instructed to confirm receipt of the recall letter and to contact Mark Scheib at (909) 906-5119 or via email at [email protected] with any questions or comments.

Root Cause

Labeling design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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