Events

Recall of Device Recall AMO Tecnis 1Piece Intraocular Lens

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Medical Optics Inc (AMO).

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
    53781
  • Event Risk Class
    Class 2
  • Event Number
    Z-0605-2010
  • Event Initiated Date
    2009-11-11
  • Event Date Posted
    2010-01-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86507
  • 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
    Abbott medical optics (amo) has received complaints of some tecnis 1-piece iols (model zcb00) have adhered to the lens optic after insertion into the eye. this can lead to a need for additional manipulation to separate the haptics from the optic during surgery which could lead to an injury.
  • Action
    Beginning on Friday, November 6, 2009, AMO began distribution of the Recall Notification Letter via Federal Express to the 874 AMO Tecnis 1-piece IOL customer accounts in the US. Included with the Recall Notification letter is a facsimile delivery confirmation that each customer was instructed to fax back to AMO to confirm receipt of the Recall Notification Letter. --- Beginning on Monday, November 9, 2009, AMO began distribution of the Recall Notification letter to the AMO Tecnis 1-piece IOL customer/distributors accounts outside the USA. "THIS RECALL NOTIFICATION DOES NOT INVOLVE TECNIS 1-PIECE IOL THAT HAVE BEEN IMPLANTED. ONCE THE HAPTICS HAVE BEEN SUCCESSFULLY DEPLOYED, THESE LENSES FUNCTION PROPERLY." Questions should be directed to an AMO Customer Service Representative at 1-877-AMO-4LIFE (1-877-266-4543).

Device

Device Recall AMO Tecnis 1Piece Intraocular Lens
  • Model / Serial
    All Serial numbers of tecnis 1-Piece Intraocular Lenses that were processed through lens surface treatment at the AMO PR facility between May 19 and October 16, 2009 - with serial numbers ending in 0906, 0907, 0908, and 0909. and subset with serial numbers ending in 0905 and 0910.  Expiration/Use By Date (YYYY-MM): 2011-05, 2011-06, 2011-07, 2011-08, 2011-09, and 2011-10
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, Hawaii, and Puerto Rico. INTERNATIONAL: Austria, Azerbaijan, Belgium, Canada, Switzerland, Cyprus, Czech Republic, Germany, Estonia, Spain, Finland, France, United Kingdom, Hungary, Ireland, Israel, Italy, Lebanon, Lichtenstein, Libya, Martinique, Netherlands, Poland, Palestine, Portugal, Saudi Arabic, Sweden, Slovenia, Turkey, and South Africa.
  • Product Description
    AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)
  • Manufacturer
    Abbott Medical Optics Inc (AMO)

Manufacturer

Abbott Medical Optics Inc (AMO)
  • Manufacturer Address
    Abbott Medical Optics Inc (AMO), 1700 E Saint Andrew Pl, Santa Ana CA 92705
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA