PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
FDA Device Recall #Z-1774-2013 — Class II — March 27, 2012
Recall Summary
| Recall Number | Z-1774-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 27, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Topcon Medical Laser Systems, Inc |
| Location | Santa Clara, CA |
| Product Type | Devices |
| Quantity | 7 US, 33 foreign |
Product Description
PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
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.
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.
Lot / 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
Other Recalls from Topcon Medical Laser Systems, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2405-2016 | Class II | Opthalmic: PASCAL Synthesis is an ophthalmic sc... | Jul 15, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.