Device product
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.
Z-0244-2023
Product summary
- Event
- Event 91041
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 95 units
- Official record key
device-enforcement:Z-0244-2023
Official wording
Reason: Due to a defect in the outer pouch sterile seal
Code information: Product Number/CFN: 9735560 UDI-DI Code: 00763000416430 Lot Numbers: 0224382403, 0224779378, 0224824522, 0224824523, 0224824525, 0224824767, 0224824768, 0224824769
Distribution pattern: U.S. Nationwide distribution including in the states AZ, CA, CO, DC, FL, IL, KY, MA, MD, ME, MI, MN, MO, NH, NJ, NY, OH, PA, RI, TX, VA, WA, and WV.
Derived failure modes
-
Unknown
Due to a defect in the outer pouch sterile seal