Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Laser Indirect Ophthalmoscope (LIO) .

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Laser Indirect Ophthalmoscope (LIO) .see related information
Date Initiated by FirmFebruary 27, 2018
Create DateMarch 16, 2018
Recall Status1 Terminated 3 on September 22, 2023
Recall NumberZ-1075-2018
Recall Event ID 79386
510(K)NumberK170718 
Product Classification Powered laser surgical instrument - Product Code GEX
ProductIridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient s retina. It allows binocular visualization of the peripheral retina and can be used to evaluate and treat patients.
Code Information Device Identity : 87300, 87301, 87302, 87303, 87304
Recalling Firm/
Manufacturer		 Iridex Corporation
1212 Terra Bella Ave
Mountain View CA 94043-1824
For Additional Information Contact
650-962-8848 Ext. 3672
Manufacturer Reason
for Recall		It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
FDA Determined
Cause 2		Device Design
ActionAction Taken by IRIDEX: 1. A investigation was started immediately upon receipt of the returned devices from the Sloan Kettering complaint on November 3, 2017. CAPA 0125 was initiated to document the events, root cause, correction, corrective and preventive action and effectiveness of these actions. 2. A ship hold was initiated on November 15, 2017. 3.As described below, IRIDEX plans to notify customers and distributors that it is voluntarily recalling all models of the TruFocus LIO Premiere. 4. Public Warning A press release was prepared and sent out on February 23, 2018. For further questions please call (650) 962-8848 Ext. 3672
Quantity in CommerceUS - 58 OUS - 46
DistributionWorldwide Distribution - USA Distribution and to the countries of : China, Germany, Australia, Canada, Ireland, Lebanon, Japan, Israel and Qatar
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GEX
-
-