Reported Aug 28, 2024 · Ongoing
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks…
Alcon Research LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 · Aspex Facility · Fort Worth, TX · 76134-2099
Is this the product you have?
- Product NameAlcon
- Custom Pak Model/Catalog NumberMany
- 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-DIsH5301ALCON1CPAK10 and H5302ALCON2CPAK20
- Model Catalog numbers
1,836 of 1,836 codes
0210-710515-650613-840775-690835-600852-750884-770900-280972-310995-8210027-1210066-1910068-1910214-2010214-2110275-1710308-1110342-1710477-2110568-1310604-0910731-2010772-3510782-3010825-1710931-1311066-0811220-2511367-2311413-1411414-0711426-2411497-1211732-161192-6711952-1511958-0811994-1512005-0912262-0612329-1612346-0812359-1412364-1312376-0312382-101239-6712417-111249-6212498-0712518-1112532-0512698-0912699-1212918-1212918-1312942-181303-6913204-1913214-21
- Lot numbers
1,555 of 1,555 codes
165FKV165DRJ165YN0165Y8W165YA5165YPJ1667A51667981668VE166EDM166EDF166C7D166H41166MY2166N03166N0Y166PNU166PM7166PMR166PNW166PMU166PPA166PP1166PPC166PN0166PNM166V8P166V7J166V6W166VR2166V6M166YH316734T16719J166YKD166YHM16716R1673RW16765V1677HD1674D01673PM1673U51677CM1673P91673NX1673PD1673R81673RC1673PH16744C16745K1677DN1674691674CY16775Y1677381677E8167876167849
- Amount recalled
- 384,851 units
This recall covers 36 products
The agency filed one notice per product. You are reading one of them; the other 35 are below.
23 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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