Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 1718
Pending LLM rewrite. Source: FDA_DEVICE Z-0939-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Ophthalmic procedure packs may have incomplete seals affecting sterility.
The recalled product
- 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 k
- Manufacturer
- Alcon Research LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
Distributed nationwide across the United States.
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