Reported Jul 16, 2025 · Ongoing
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected…
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 · 6201 South Fwy · Fort Worth, TX · 76134-2099
Is this the product you have?
- Brand NameAlcon Laboratories, Inc
- Product NameCustom
- Pak Model/Catalog NumberMany - See 'Attachment 1 -
- Affected Product List' 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
17 of 17 products
Products covered by this recall Model / number Barcodes Product as published 10K5414660400332C17655-06 17CU88 I-CPKB-VITREO 23GA 10K5414660400332C17951-09 179UFL F-GSH VITREC CONSTEL 23G 7.55414660540632C18093-04 17AP8L F-CPKB-CL MONTICELLI CONST 25G+ V 5414660421078 C18093-04 17CJWE F-CPKB-CL MONTICELLI CONST 25G+ V 5414660421078 C18103-09 17D512 F-CH VILLEFRANCHE CONSTELLATIO 5414660461791 C19081-11 1790C9 E-PAK PARA VIT 23G CONST 5414660535997 C19081-11 17A6T7 E-PAK PARA VIT 23G CONST 5414660535997 C19154-10 178YWP E-PAK VITREO CONST 23G 10K5414660489818C19283-09 179LEN F-ST ROCH CONSTEL 23G V 10K5414660526384C19283-09 17C732 F-ST ROCH CONSTEL 23G V 10K5414660526384C19619-11 179NJ0 P-VITRECTOMIA 5414660535607 C19619-11 17CK19 P-VITRECTOMIA 5414660535607 C19676-17 17CHY8 SF-TAKAOSAPAKKAU 5414660545002 C19788-05 17D832 F-HCL CONSTEL MIC 2.25414660544784C19827-16 179J9Y PL-LUBLIN SPSK1 CONST 23G5414660535423C19827-16 17CD4M PL-LUBLIN SPSK1 CONST 23G5414660535423C19886-13 178W74 E-PAK VITREO CONST 25G 20K5414660527350C19886-13 17A0KD E-PAK VITREO CONST 25G 20K5414660527350C19899-16 179DRK PL-WROCLAW WSS CONST 23G5414660536543C19940-07 17CRRK F-COURLANCY REIMS VITRE 25G+ V 5414660427759 C19988-23 17ACWA PL-W-WA SPKSO CONST 25G+ 5414660542735 C19988-23 17C2EJ PL-W-WA SPKSO CONST 25G+ 5414660542735 C20382-07 179UR0 E-PAK VITREO CONST 23G 10K5414660434665C20452-09 17C49D P-VITRECTOMIA 5414660506799 C20486-18 17CLME PL-BIELAWA OKULISTYKA CONST 25G5414660547754C20578-09 17A7N2 F-ST JEAN DE DIEU CONS 25G+ 10 5414660546535 C20592-11 17A9CV E-PAK CONSTELLATION 25G 20K5414660513889C20592-11 17CRDL E-PAK CONSTELLATION 25G 20K5414660513889C20678-10 17955U P-VITRECTOMIA 5414660535102 C20678-10 17C25J P-VITRECTOMIA 5414660535102 C20681-12 17AEKF P-VITRECTOMIA 5414660539544 C20682-11 17A2M6 P-VITRECTOMIA 5414660539360 C20682-11 17CLTR P-VITRECTOMIA 5414660539360 C20781-07 179X7T GB-POSTERIOR 25G 10K5414660503286C21175-07 1787KC P-VITRECTOMIA 5414660434443 C21175-07 179FFU P-VITRECTOMIA 5414660434443 C21295-09 17A4Y5 P-VIT CONSTELLATION 23G V 541 - Amount recalled
- 15557 kits
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
This product could cause temporary or reversible health problems — stop using it.
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