Z-1844-2011

Ellex Solo LT5106-S ophthalmic laser (not sold in USA)

Name: Z-1844-2011 Ellex Solo LT5106-S ophthalmic laser (not sold in USA)
Creator: Ellex Medical Pty Ltd
Published: 2011-02-15
License: https://open.fda.gov/license/

Ellex Medical Pty Ltd / initiated 2011-02-15 / Terminated / root cause: manufacturing process

FDA source

Ellex Medical Pty Ltd began a recall of Ellex Solo LT5106-S ophthalmic laser (not sold in USA) on 2011-02-15. The reason FDA records is "Unintended laser emission while the user was moving the joystick for targeting". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1844-2011
Status: Terminated
Initiated: 2011-02-15
Posted: 2011-04-12
Terminated: 2012-10-02
Recalling firm: Ellex Medical Pty Ltd
Product: Ellex Solo LT5106-S ophthalmic laser (not sold in USA)
Product code: HQF Laser, Ophthalmic
Reason for recall: Unintended laser emission while the user was moving the joystick for targeting.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Ellex notified all distributors that have received the affected devices per Global Customer Service Bulletin GSB-11 -01a, dated 25 February 2011.
Quantity in commerce: 193 units
Distribution: worldwide distribution
Product codes and lots: Units manufactured between August 2007 and 20 February 2011.

Product code HQF

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)