Events

Recall of Device Recall NonCertified laser diode component

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ii - Vi Incorporated.

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
    80020
  • Event Risk Class
    Class 2
  • Event Number
    Z-1614-2018
  • Event Initiated Date
    2017-12-13
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164228
  • 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
    unknown device name - Product Code N/A
  • Reason
    Affected diodes incorporated in the laser sights emitted greater than the 5 mw limit.
  • Action
    Please note that II-VI Inc. is responsible for the correction of all noncompliant products should the reported epoxy processing defect adversely affect any other laser diodes manufactured by II-VI, Inc. The single customer, Crimson Trace Corporation CTC was formally notified by you in writing. The defective laser diodes, models 25-0655 & 25-0657 will be or have already been replaced at no cost to CTC. The replacement will be done in batches and is expected to take approximately six to nine months, or no later than January 31, 2019. Defective laser diodes will be either returned to II-VI or destroyed at CTC. For further questions, please call (724) 352-4455.

Device

Device Recall NonCertified laser diode component
  • Model / Serial
    Model Numbers: 25-0655 & 25-0657
  • Distribution
    US Distribution to Oregon.
  • Product Description
    11-VI Incorporated Laser diode component || Non-certified laser diode component used in laser sights for firearms
  • Manufacturer
    Ii - Vi Incorporated

Manufacturer

Ii - Vi Incorporated
  • Manufacturer Address
    Ii - Vi Incorporated, 375 Saxonburg Blvd, Saxonburg PA 16056-9430
  • Manufacturer Parent Company (2017)
    II-VI, Inc.
  • Source
    USFDA