Topcon Medical Laser Systems, Inc: Medical Device Recall in 2013 - (Recall #: Z-1774-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 27, 2012

Date Posted: July 31, 2013

Recall Number: Z-1774-2013

Event ID: 65688

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.

Status: Terminated

Product Quantity: 7 US, 33 foreign

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated