Events

Recall of Model LightLas 532 Opthalmic Photocoagulator Laser

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by LightMed USA 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
    27819
  • Event Risk Class
    Class 2
  • Event Number
    Z-0228-04
  • Event Initiated Date
    2003-11-11
  • Event Date Posted
    2003-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30572
  • 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
    Firm needed to include calibration procedures in user guide.
  • Action
    Firm fedexed new user manuals with calibration procedures to each consignee on 11/11/2003.

Device

Model LightLas 532 Opthalmic Photocoagulator Laser
  • Model / Serial
    All codes
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, GA
  • Product Description
    Model LightLas 532 Opthalmic Photocoagulator Laser
  • Manufacturer
    LightMed USA Inc

Manufacturer

LightMed USA Inc
  • Manufacturer Address
    LightMed USA Inc, 1030 Calle Cordillera Ste 101, San Clemente CA 92673-6234
  • Source
    USFDA