Events

Recall of Device Recall KAMRA INLAY

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

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
    73343
  • Event Risk Class
    Class 2
  • Event Number
    Z-1235-2016
  • Event Initiated Date
    2016-02-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143915
  • 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
    Implant, corneal, refractive - Product Code LQE
  • Reason
    Acufocus is recalling kamra aci 7000 corneal inlays due to concerns with the labeled shelf life.
  • Action
    The firm, AcuFocus, sent an "URGENT FIELD SAFETY NOTICE" letter dated 2/11/16 to all their customers to inform them that AcuFocus is recalling 2 lots of KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life. The described the product, problem and the actions to be taken. Customers are instructed to report any abnormal appearance of the implanted KAMRA inlay to AcuFocus, inc; stop using and remove from your inventory all affected lots; complete and return the attached Customer Recall Response Form via email: customerservice@acufocus.com, Fax: +1 (949) 585-9545 Attn: Recall Coordinator, or mail to: AcuFocus Inc., Attn: Recall Coordinator, 32 Discovery, Suite 200, Irvine CA 92618, within 3 business days even if you have no inventory affected by this recall; and provide the attached Customer Field Safety Notice and Customer Recall Response Form to your customers who have or may have received product from the affected two lots. Customers with product complaint events are instructed to report regarding KAMRA inlays involved in this recall event, and to inform AcuFocus, Inc. by calling +1 (949) 585-9511 ext 608. Customers with any questions related to the return process, are instructed to contact an AcuFocus Customer Service Representative at +1 (949) 585-9511 ext 608.

Device

Device Recall KAMRA INLAY
  • Model / Serial
    Lots A534-1014 and A535-1014
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    International distribution in countries of: Canada, Germany, Saudi Arabia, Turkey, and United Kingdom.
  • Product Description
    KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 || (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient.
  • Manufacturer
    AcuFocus, Inc.

Manufacturer

AcuFocus, Inc.
  • Manufacturer Address
    AcuFocus, Inc., 32 Discovery Ste 200, Irvine CA 92618-3161
  • Manufacturer Parent Company (2017)
    AcuFocus Inc.
  • Source
    USFDA