Events

Recall of Device Recall OASIS Medical Vidaurri LASIK Flap Irrigator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Oasis Medical 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
    33431
  • Event Risk Class
    Class 2
  • Event Number
    Z-1600-05
  • Event Initiated Date
    2005-08-24
  • Event Date Posted
    2005-10-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42507
  • 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
    Device, Irrigation, Ocular Surgery - Product Code KYG
  • Reason
    "please be aware that this is not a new recall. this recall was initially classified in 2005 (z-1595-05). the firm has taken action; but, due to administrative issues this product is now being classified by the agency". foreign deposit present on the surface of the vidaurri lasik flap irrigators.
  • Action
    OASIS Medical shall inform all customers that have received the product via FAX and Certified Mail to cease use immediately and return all unused product to OASIS.

Device

Device Recall OASIS Medical Vidaurri LASIK Flap Irrigator
  • Model / Serial
    Product Specification MK-036V Lot D0305Y
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Chile, England, Ecuador,Greece, Italy, India, Kuwait, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Spain, Sweden, and Switzerland
  • Product Description
    OASIS Medical Vidaurri LASIK Flap Irrigator, Non-sterilized Bulk, Product Specification MK-036V, LASIK Flap Irrigator (Vidaurri) || The MK-03V cannula is placed into a vacuum formed plastic tray and a blank Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is placed into a Tyvek pouch, heat-sealed and placed into a polybag. The polybag is sealed and labeled. Typically there are 100 pouches per polybag.
  • Manufacturer
    Oasis Medical Inc

Manufacturer

Oasis Medical Inc
  • Manufacturer Address
    Oasis Medical Inc, 512 S Vermont Ave, Glendora CA 91741-6205
  • Source
    USFDA