UV-Absorbing Posterior Chamber IOL Model: RS-55B, Serial Number: 1167121106, 1167131106, 1167141106, 1167151106, 1167161

FDA device recall Z-1078-2012 · posted 2012-02-22 · Terminated

Recall details

Recalling firm

Aaren Scientific, Incorporated

Reason for recall

The recall was initiated because Aaren Scientific has confirmed that a specific group of lenses were shipped without a complete expiry date showing on the label.

Action taken

Aaren Scientific sent a recall communication letter dated August 2, 2011, August 3, 2011, and August 30, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Aaren Scientific is requesting that you return the lenses and we will rework the product and return them back to you. Please let me know and I will issue an RGA number and inform you of our FedEx account number to reference. In the meantime, we are conducting an internal investigation regarding this issue. Once this has been closed out then we will notify you of our findings. For further questions please call (909) 937-1033 ext. 108.

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

HQL

Quantity affected

135 units

Distribution

Worldwide Distribution - USA including CA and TN, and the countries of India and Lebanon.

Date initiated

2011-08-02

Date posted

2012-02-22

Date terminated

2012-08-10

Location

Ontario, CA