Lutronic Corporation has recalled 1,525 Clarity II Laser Systems due to reports of the devices sparking or popping. These malfunctions can lead to potential burn injuries for patients during medical procedures. The recall affects Model No. 1110200210 distributed worldwide, including nationwide in the United States.
The laser systems can spark or pop during use, which poses a direct risk of thermal burns to patients being treated with the device. Lutronic has received reports of devices popping and sparking, confirming the potential for patient harm.
Units manufactured in Korea (the Republic of).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.