Events

Recall of Device Recall Alden Classic 38

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

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
    79377
  • Event Risk Class
    Class 2
  • Event Number
    Z-0983-2018
  • Event Initiated Date
    2017-11-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162152
  • 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
    Lenses, soft contact, daily wear - Product Code LPL
  • Reason
    Contact lenses lack sterility assurance.
  • Action
    Consignees were initially called and told over the phone not to further distribute the contact lenses. For two consignees whose patients could not be reached by phone, a letter was sent. The consignee letter states the specific product and lot should not be further distributed due to the lack of sterility assurance. A business reply card was provided with the letter and contacts should be returned to the manufacturer using a label provided by the firm.

Device

Device Recall Alden Classic 38
  • Model / Serial
    AZ034720 AZ152310 AZ152320
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states:of CA, FL, GA, ID, IL, IN, KS, KY, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, TX, VA, WI, WY and the country of Canada.
  • Product Description
    Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 || Product Usage: || The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia). The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.
  • Manufacturer
    Alden Optical

Manufacturer

Alden Optical
  • Manufacturer Address
    Alden Optical, 6 Lancaster Pkwy, Lancaster NY 14086-9713
  • Manufacturer Parent Company (2017)
    Alden Optical Laboratory Inc
  • Source
    USFDA