Z-1075-2018Class II

Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect...

Name: Z-1075-2018 Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect...
Creator: Iridex Corporation
Published: 2018-02-27
License: https://open.fda.gov/license/

Iridex Corporation / initiated 2018-02-27 / Terminated / root cause: design

FDA source

Iridex Corporation began a recall of Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view... on 2018-02-27. FDA classified it as Class II and gives the reason as "It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1075-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-27
Posted: 2018-03-16
Terminated: 2023-09-22
Recalling firm: Iridex Corporation
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.
Product code: GEX Powered Laser Surgical Instrument
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.
Root cause tag: design
FDA root cause: 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
Product codes and lots: Device Identity : 87300, 87301, 87302, 87303, 87304

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1075-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1075-2018	Class II	Terminated	FDA Mandated	2018-03-28	2018-03-16

Product code GEX

K170718Class IIIridex TruFocus LIO PremiereIridex Corporation / cleared 2017-05-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)