Iridex TruFocus LIO Premiere" Laser Indirect recall
Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a handheld…
Why was Iridex TruFocus LIO Premiere" Laser Indirect recalled?
It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Device Identity : 87300, 87301, 87302, 87303, 87304
- Product
- Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a handheld…
- Recalling firm
- Iridex Corporation
- Quantity
- US - 58 OUS - 46
- Distribution
- Worldwide Distribution - USA Distribution and to the countries of : China, Germany, Australia, Canada, Ireland, Lebanon, Japan, Israel and Qatar
- Recall date
- March 28, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)