Z-1270-2016Class II

Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount...

Name: Z-1270-2016 Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount...
Creator: Laserex Systems Inc.
Published: 2016-02-01
License: https://open.fda.gov/license/

Ellex Medical Pty Ltd / initiated 2016-02-01 / Terminated / root cause: design

FDA source

Laserex Systems Inc. began a recall of Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents... on 2016-02-01. FDA classified it as Class II and gives the reason as "The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented". 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-1270-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-01
Posted: 2016-04-07
Terminated: 2016-10-27
Recalling firm: Ellex Medical Pty Ltd
Product: Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. .
Product code: HQF Laser, Ophthalmic
Reason for recall: The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented.
Root cause tag: design
FDA root cause: Device Design
Action: Ellex Medical Pty Ltd. Planned Action to bring into Compliance: 1.Field Corrective Action replacing all affected safety filters of all units manufactured between July 2012 and February 2016, 2.All repairs will be made at no cost to the purchaser; and 3.The corrections will be completed by March 30, 2017. CDRH approves the CAP subject to the following conditions: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. For further questions please call (800) 824-7444.
Quantity in commerce: 72 units plus 2 spare units
Distribution: Worldwide Distribution - US Distribution
Product codes and lots: Model Number : 3143270

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1270-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1270-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-07

Product code HQF

K052777Class IILaserex Duo Family of Dual Wavelength Ophthalmic Lasers Including Models Integre Duo Lp1rg-S, Lp1rg-DEllex Medical Pty, Ltd. / cleared 2006-03-16

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)