Events

Recall of SP65A2 UVAbsorbing Posterior Chamber Intraocular Lens

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aaren Scientific, Incorporated.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60962
  • Event Risk Class
    Class 3
  • Event Number
    Z-1079-2012
  • Event Initiated Date
    2011-08-02
  • Event Date Posted
    2012-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106908
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Intraocular lens - Product Code HQL
  • Reason
    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
    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.

Device

SP65A2 UVAbsorbing Posterior Chamber Intraocular Lens
  • Model / Serial
    Lot Number: 110617
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA including CA and TN, and the countries of India and Lebanon.
  • Product Description
    UV-Absorbing Posterior Chamber IOL || Model: SP-65A2, || Serial Number: || 1168471106, 1168481106, 1168491106, 1168501106, 1168511106, 1168521106, 1168531106, 1168541106, 1168551106, 1168561106, 1168571106, 1168581106, 1168591106, 1168601106, 1168611106. || 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.
  • Manufacturer
    Aaren Scientific, Incorporated

Manufacturer

Aaren Scientific, Incorporated
  • Manufacturer Address
    Aaren Scientific, Incorporated, 4290 E Brickell St Ste A, Ontario CA 91761-1569
  • Manufacturer Parent Company (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA