FDA Medical devices recall ·
Alcon Laboratories, Inc recall
- Recall number
- Z-2109-2025
- Date
- (initiated April 28, 2025)
- Company / brand
- Alcon Research LLC
6201 South Fwy, Fort Worth, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 89495
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. 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' Product Description: TOTAL PLUS PAK,23G,5.0 CPM,STDRFID Catalog Number: 8065751058 UDI-DI code: 380657510580 Lot Numbers: 1762K1 176WTW 177TVD 179EE9 179EEA Product Description: COMBINED PAK,23G,5.0 CPM,0.9STD,RFID Catalog Number: 8065751077 UDI-DI code: 380657510771 Lot Number: 178D4X Product Description: ANTERIOR PAK,0.9,W/0 PROBE/IL-LUMINATIO Catalog Number: 8065751155 UDI-DI code: 380657511556 Lot Numbers: 1782FY 1782H0 1782H1 178D4Y 178D51 178D52 178RYU 178RYV 178RYW 178RYX 1792YK 179EED 179EEE 179EEF 179EEH 179TXM 179TXN 179TXP 17AVLU 17AVLV 17C7H2 17CNRM 17CNRN 17CNRP 17CNRR 17CNRT Product Description: 23G POST TPP VAL STD 7500 Catalog Number: 8065751613 UDI-DI code: 380657516131 Lot Numbers: 1754MX 1754T1 175M41 1762K7 176CC8 176CC9 176CCA 176WU5 17769P 1782HA 1782HC 178D54 179EEJ 179TXU 17AFT8 17AVLW 17C7FX 17C7FY Product Description: TOTAL PLUS,25+ 7.5CPM VALVE Catalog Number: 8065751617 UDI-DI code: 380657516179 Lot Numbers: 1762K8 1762KD 176CCD 176WU6 17769R 1782HD 1782HE 178D56 178T0A 178T0C 179EEK 179EEL 17A4WL 17AFT9 17C7FV 17C7FW Product Description: TPP CONST 25+ SHORT 7500CPM Catalog Number: 8065751715 UDI-DI code: 380657517152 Lot Number: 1792YP Product Description: 23G CMB PAK 7.5CPM V STD 0.9 Catalog Number: 8065751765 UDI-DI code: 380657517657 Lot Numbers: 1782HJ 178D58 178T96 179302 Product Description: 25+ CMB PAK 7.5CPM,V,STD 0.9 Catalog Number: 8065751767 UDI-DI code: 380657517671 Lot Number
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-2109-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.