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U.S. Department of Health and Human Services

Class 2 Device Recall Laser Indirect Ophthalmoscope (LIO) .

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  Class 2 Device Recall Laser Indirect Ophthalmoscope (LIO) . see related information
Date Initiated by Firm February 27, 2018
Create Date March 16, 2018
Recall Status1 Terminated 3 on September 22, 2023
Recall Number Z-1075-2018
Recall Event ID 79386
510(K)Number K170718  
Product Classification Powered laser surgical instrument - Product Code GEX
Product Iridex 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
Action Action 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 Commerce US - 58 OUS - 46
Distribution Worldwide Distribution - USA Distribution and to the countries of : China, Germany, Australia, Canada, Ireland, Lebanon, Japan, Israel and Qatar
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = GEX and Original Applicant = Iridex Corporation
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