Device product
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
Z-0939-2026
Product summary
- Event
- Event 98055
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 151 units
- Official record key
device-enforcement:Z-0939-2026
Official wording
Reason: Ophthalmic procedure packs may have incomplete seals affecting sterility.
Code information: UDI: *+H5301ALCON1CPAK10B* /9903-20 - Lot #17PJ9X, 17188-04 - Lot # 17PJAY, 19762-03 - Lot # 17PU09, 19203-04- Lot # 17PMWE, 19203-04 - Lot # 17PTXP, 17957-10- Lot #17PTXY
Distribution pattern: US Nationwide distribution in the states of CA, ND, UT.
Derived failure modes
-
Unknown
Ophthalmic procedure packs may have incomplete seals affecting sterility.