Events

Recall of INTRAOCULAR LENS MODEL P32UV

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAUSCH & LOMB 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
    109722
  • Event Risk Class
    II
  • Event Initiated Date
    2001-06-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The tyvek/mylar film pouch provides a sterile barrier is a two part laminate with an adhesive between a defect in the adhesive application process has allowed the layers to separate.

Device

INTRAOCULAR LENS MODEL P32UV
  • Model / Serial
    Model Catalog: P329UV (Lot serial: 6JAG07.); Model Catalog: P329UV (Lot serial: 6MFM02 6MFU01 6MFW01); Model Catalog: P328UV (Lot serial: 6KCW10.); Model Catalog: P328UV (Lot serial: 6JAG06 6KC708 6KC710); Model Catalog: P328UV (Lot serial: 6KCW11 6KC709 6KCW06)
  • Product Description
    INTRAOCULAR LENS
  • Manufacturer
    BAUSCH & LOMB INC.

Manufacturer

BAUSCH & LOMB INC.