Alcon Research LLC: Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 1795
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Alcon Research LLC
- 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
- Reason / hazard
- Ophthalmic procedure packs may have incomplete seals affecting sterility.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of CA, ND, UT.
- Recall initiated
- 2025-11-24
- Code info
- 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
- Product quantity
- 151 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Fort Worth
- State
- TX
- Country
- United States
- Event id
- 98055
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