Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedur...
FDA Device Recall #Z-2109-2025 - Class II, April 28, 2025
Recall Summary
| Recall Number | Z-2109-2025 |
| Classification | Class II - Moderate risk |
| Date Initiated | April 28, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Alcon Research LLC |
| Location | Fort Worth, TX |
| Product Type | Devices |
| 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.
Lot / 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 from Alcon Research LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0939-2026 | Class I | Brand Name: Alcon Laboratories, Inc. Product N... | Nov 24, 2025 |
| Z-0326-2026 | Class II | Alcon PRECISION1 One-Day Contact Lenses, -2.25D. | Sep 30, 2025 |
| Z-0581-2026 | Class II | CONSTELLATION ULTRAVIT 10K and CONSTELLATION HY... | Sep 15, 2025 |
| Z-0305-2026 | Class II | Brand Name: Alcon Laboratories, Inc. Product N... | Aug 5, 2025 |
| Z-0308-2026 | Class II | Brand Name: Alcon Laboratories, Inc. Product N... | Aug 5, 2025 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately, you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.