Events

Recall of Device Recall PASCAL and PASCAL Streamline

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Topcon Medical Laser Systems, 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
    65688
  • Event Risk Class
    Class 2
  • Event Number
    Z-1774-2013
  • Event Initiated Date
    2012-03-27
  • Event Date Posted
    2013-07-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119881
  • 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
    Laser, ophthalmic - Product Code HQF
  • Reason
    When using the "favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. this may result in over or under treatment.
  • Action
    Initial notification was sent on March 27, 2012 to all TMLS Distribution Partners and Sales Representative. This was followed by a follow up notification on June 4, 2012. A final notice was sent on February 11, 2013 to all those who had not sent documentation that the field action had been implemented.

Device

Device Recall PASCAL and PASCAL Streamline
  • Model / Serial
    PASCAL Standard 2R/G System v2.x.x and PASCAL Streamline 2R/G Software v2.x.x Serial numbers: United States 33057910 33060410 33063610 66078611 66084911 66085111 66085511 Out of United States OMC-179 11138509 11141209 11147209 11147809 11148910 11149010 11149210 11149710 . 11149810 11150110 11150210 11150410 11150610 11150810 11150910 11151010 1 151110 11151211 33054310 33059310 33059510 33062810" 66075211' 66076711 66077111 66078011 66079911 6608391'1 66084611 66084811 66085011 66085211
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA and the countries of China, Hong Kong, Brazil, France, Japan, Netherlands, Pakistan, Malaysia, United Kingdom, South Korea, Thailand, Dubai, and South Africa.
  • Product Description
    PASCAL and PASCAL Streamline (532 nm.577 nm); || Treats the patient's eye.
  • Manufacturer
    Topcon Medical Laser Systems, Inc

Manufacturer

Topcon Medical Laser Systems, Inc
  • Manufacturer Address
    Topcon Medical Laser Systems, Inc, 3130 Coronado Dr, Santa Clara CA 95054-3205
  • Manufacturer Parent Company (2017)
    Topcon Corporation
  • Source
    USFDA