Reported Dec 31, 2025 · Ongoing
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03,…
Alcon Research LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alcon Research LLC · 6201 South Fwy · Fort Worth, TX · 76134-2099
Is this the product you have?
- Brand NameAlcon Laboratories, Inc
- Product NameCustom
- Pak Model/Catalog Numbers
9903-2017188-0419762-0319203-0419203-0417957-10
- Software VersionN/A
- Product DescriptionAlcon 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
- ComponentN/A
- Lot codes and dates
- UDI
*+H5301ALCON1CPAK10B* /9903-20 - Lot #17PJ9X17188-04 - Lot # 17PJAY19762-03 - Lot # 17PU0919203-04- Lot # 17PMWE19203-04 - Lot # 17PTXP17957-10- Lot #17PTXY
- UDI
- Amount recalled
- 151 units
Where it was sold
Why it was recalled
Stop using this product now
Ophthalmic procedure packs may have incomplete seals affecting sterility.
Using this product could cause serious injury, illness or death — stop using it now.
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