FDA Medical devices recall · July 16, 2025

Alcon Laboratories, Inc recall

Read the official FDA notice ↗

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

Why was it 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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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 VITRECTOMY 25G NORTHSIDE HOSP 380655178492 1137-65 17A46H CATARACT FRENCH HOSP CORP 380653436938 1137-65 17CXY9 CATARACT FRENCH HOSP CORP 380653436938 12568-09 178PTE 23G CONSTELLATION NORTHERN MICH SPPLY AL 380653414561 12568-09 17CK02 23G CONSTELLATION NORTHERN MICH SPPLY AL 380653414561 12641-14 178KD6 AUS-25GA VIT RET BRISBANE WATERS 380655181935 12852-16 179N1E AUS-23GA 10K COMBINED VR PAK NEW CHILDRE 380655158425 13110-11 17AKR3 23GA CVS RETINA TPP V A HOSP HOUSTON 380655177549 13501-08 177D

Distribution

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Ecuador, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Luxembourg, Macao, Malaysia, Malta, Mexico, Moldova, Mongolia, Montenegro, Morocco, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Qatar, Republic of North Macedonia, R¿union, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam.

States: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-2110-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.