Z-1078-2012

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

Name: Z-1078-2012 UV-Absorbing Posterior Chamber IOL Model: RS-55B, Serial Number: 1167121106, 1167131106, 1167141106...
Creator: Aaren Scientific, Incorporated
Published: 2011-08-02
License: https://open.fda.gov/license/

Aaren Scientific Inc. / initiated 2011-08-02 / Terminated / root cause: labeling and UDI

FDA source

Aaren Scientific, Incorporated began a recall of UV-Absorbing Posterior Chamber IOL Model: RS-55B, Serial Number: 1167121106, 1167131106, 1167141106, 1167151106, 1167161106, 1167171106, 1167181106... on 2011-08-02. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1078-2012
Status: Terminated
Initiated: 2011-08-02
Posted: 2012-02-22
Terminated: 2012-08-10
Recalling firm: Aaren Scientific Inc.
Product: UV-Absorbing Posterior Chamber IOL Model: RS-55B, Serial Number: 1167121106, 1167131106, 1167141106, 1167151106, 1167161106, 1167171106, 1167181106, 1167191106, 1167201106, 1167211106, 1167221106, 1167231106, 1167241106, 1167251106, 1167261106, 1167271106, 1167281106, 1167291106, 1167301106, 1167311106, 1167321106, 1167331106, 1167341106, 1167351106, 1167361106, 1167371106, 1167381106, 1167391106, 1167401106, 1167411106, 1167421106, 1167431106, 1167441106, 1167451106, 1167461106, 1167471106, 1167481106, 1167491106, 1167501106, 1167511106, 1167521106, 1167531106, 1167541106, 1167551106, 1167561106, 1167571106, 1167581106, 1167591106, 1167601106, 1167611106, 1167621106, 1167631106, 1167641106, 1167651106, 1167661106, 1167671106, 1167681106, 1167691106, 1167701106, 1167711106, 1167721106, 1167731106, 1167741106, 1167751106, 1167761106, 1167771106, 1167781106, 1167791106, 1167801106, 1167811106, 1167821106, 1167831106, 1167841006, 1167851106, 1167861106, 1167871106, 1167881106, 1167891106, 1167901106, 1167911106, 1167921106, 1167931106, 1167941106, 1167951106, 1167961106, 1167971106, 1167981106, 1167991106, 1168001106, 1168011106, 1168021106, 1168031106, 1168041106, 1168051106, 1168061106, 1168071106, 1168081106, 1168091106, 1168101106, 1168111106, 1168121106, 1168131106, 1168141106, 1168151106, 1168161106, 1168171106, 1168181106, 1168191106, 1168201106, 1168211106, 1168221106, 1168231106, 1168241106, 1168251106, 1168261106, 1168271106, 1168281106, 1168291106, 1168301106, 1168311106, 1168321106, 1168331106, 1168341106, 1168351106, 1168361106, 1168371106, 1168381106, 1168391106, 1168401106, 1168411106, 1168421106, 1168431106, 1168441106, 1168451106, 1168461106. 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.
Product code: HQL Intraocular Lens
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.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: 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.
Quantity in commerce: 135 units
Distribution: Worldwide Distribution - USA including CA and TN, and the countries of India and Lebanon.
Product codes and lots: Lot Number: 110617

Product code HQL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)