Home / Recalls / Alcon Research LLC / Z-2109-2025

Z-2109-2025 Class II Ongoing

Recalled by Alcon Research LLC — Fort Worth, TX

Recall Details

Product Type
Devices
Report Date
July 16, 2025
Initiation Date
April 28, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
89495

Product Description

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

Reason for Recall

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.

Distribution Pattern

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.

Code Information

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 Numbers: 1782HL 178DE4 178T97 179308 179EEP 179EER 179TXX 17A4WP 17AFW2 17C7FP 17C7FR Product Description: CNST ANTERIOR PK,0.9MM,W/O PROBE,BNB Catalog Number: 8065751865 UDI-DI code: 380657518654 Lot Numbers: 178DE6 178DE7 178T9A 178T9C 17930C 17930D 179EET 179EEU 17AVM3 17AVM4 17C7H8 17C7H9 17CKP5 17CKP6 17CXF0 17CXF1 Product Description: 23G CMB PAK 10K CPM,V,STD 0.9 Catalog Number: 8065752448 UDI-DI code: 380657524488 Lot Numbers: 1782J3 1782J4 178TA4 178DEH 17930J 17930K 179EH3 179EFK 179TYL 17A4XE 17AVMC 17AVMD 17AVME 17C7F2

Other recalls by Alcon Research LLC

  • Z-0939-2026 Class I — Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Nu (November 24, 2025)
  • Z-0326-2026 Class II — Alcon PRECISION1 One-Day Contact Lenses, -2.25D. (September 30, 2025)
  • Z-0581-2026 Class II — CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ (September 15, 2025)
  • Z-0306-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
  • Z-0307-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
  • Z-0308-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
  • Z-0305-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
  • Z-0304-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
  • Z-2108-2025 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System (April 28, 2025)
  • Z-2110-2025 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Nu (April 28, 2025)