Z-1774-2013Class II

PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye

Name: Z-1774-2013 PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye
Creator: Topcon Medical Laser Systems, Inc
Published: 2012-03-27
License: https://open.fda.gov/license/

Iridex Corporation / initiated 2012-03-27 / Terminated / root cause: software

FDA source

Topcon Medical Laser Systems, Inc began a recall of PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye on 2012-03-27. FDA classified it as Class II and gives the reason as "When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1774-2013
Classification: Class II
Status: Terminated
Initiated: 2012-03-27
Posted: 2013-07-19
Terminated: 2013-07-19
Recalling firm: Iridex Corporation
Product: PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
Product code: HQF Laser, Ophthalmic
Reason for recall: When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment.
Root cause tag: software
FDA root cause: Software design
Action: Initial notification was sent on March 27, 2012 to all TMLS Distribution Partners and Sales Representative. This was followed by a follow up notification on June 4, 2012. A final notice was sent on February 11, 2013 to all those who had not sent documentation that the field action had been implemented.
Quantity in commerce: 7 US, 33 foreign
Distribution: Worldwide Distribution-USA and the countries of China, Hong Kong, Brazil, France, Japan, Netherlands, Pakistan, Malaysia, United Kingdom, South Korea, Thailand, Dubai, and South Africa.
Product codes and lots: PASCAL Standard 2R/G System v2.x.x and PASCAL Streamline 2R/G Software v2.x.x Serial numbers: United States 33057910 33060410 33063610 66078611 66084911 66085111 66085511 Out of United States OMC-179 11138509 11141209 11147209 11147809 11148910 11149010 11149210 11149710 . 11149810 11150110 11150210 11150410 11150610 11150810 11150910 11151010 1 151110 11151211 33054310 33059310 33059510 33062810" 66075211' 66076711 66077111 66078011 66079911 6608391'1 66084611 66084811 66085011 66085211

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1774-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1774-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-19

Product code HQF

K100019Class IIPascal Streamline PhotocoagulatorOptimedica Corporation / cleared 2010-05-04

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)