FDA Device recall Z-2110-2025

Brand Name: Alcon Laboratories, Inc

FDA Device
Class II
ongoing
Published 2025-07-16

On 2025-07-16 the FDA classified a Class II recall of Brand Name: Alcon Laboratories, Inc by Alcon Research, citing 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 damag….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2110-2025
Classification	Class II
Status	ongoing
Initiated	2025-04-28
Published	2025-07-16
Last updated	2026-09-13 11:57 UTC
Company	Alcon Research
Distribution	US

Product

Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 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

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.

Identifiers

code_info	Lot Code: Many - See 'Attachment 1 - Affected Product List' Catalog Number / Lot Number / Custom Pak Description/ UDI-… Lot Code: Many - See 'Attachment 1 - Affected Product List' Catalog Number / Lot Number / Custom Pak Description/ UDI-DI code: 0094-77 17C3H9 J-CAT PAK - CVS KENRITSU NINOHE HP 380655137888 10366-13 17CY90 AUS-CATARACT BRISBANE WATERS 380655161951 10924-15 176JX0 25G VIT 25G OPTICARE EYE HLTH CTR 380651690714 11201-11 17A18R AUS-DR CH KHONG ST JOHN OF GOD GERALDTON 380655184899 11201-11 17A1AW AUS-DR CH KHONG ST JOHN OF GOD GERALDTON 380655184899 11220-27 176NYN VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 1772HN VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 1772L9 VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 177URH VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 179TKU VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17CF2K VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17AMJJ VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17AMMW VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17CLCN VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 179Y3T V

code_info

Lot Code: Many - See 'Attachment 1 - Affected Product List' Catalog Number / Lot Number / Custom Pak Description/ UDI-…

Lot Code: Many - See 'Attachment 1 - Affected Product List' Catalog Number / Lot Number / Custom Pak Description/ UDI-DI code: 0094-77 17C3H9 J-CAT PAK - CVS KENRITSU NINOHE HP 380655137888 10366-13 17CY90 AUS-CATARACT BRISBANE WATERS 380655161951 10924-15 176JX0 25G VIT 25G OPTICARE EYE HLTH CTR 380651690714 11201-11 17A18R AUS-DR CH KHONG ST JOHN OF GOD GERALDTON 380655184899 11201-11 17A1AW AUS-DR CH KHONG ST JOHN OF GOD GERALDTON 380655184899 11220-27 176NYN VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 1772HN VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 1772L9 VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 177URH VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 179TKU VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17CF2K VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17AMJJ VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17AMMW VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 17CLCN VITRECTOMY 25G NORTHSIDE HOSP 380655178492 11220-27 179Y3T V

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2110-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.