Recall Z-0305-2026 ยท HQC Unit, Phacofragmentation
Alcon Research LLC
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 80657
| Date | Oct 24, 2025 (initiated Aug 5, 2025) |
| Status | Open, Classified |
| Reason | Due to incomplete seals in the pouch which provide the sterile barrier. |
| Root cause | Process control |
| Action | On 08/05/2025, the firm sent via FedEx Overnight an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that for the Alcon Standalone Vitrectomy Consumables, there is potential for some pouches within impacted lots to have an incomplete seal. Customers are instructed to: locate and dispose of any affected lots of Alcon Standalone Vitrectomy Consumables remaining in your inventory. To comply with this Medical Device Recall and request the replacement of any unused product, please take the following steps: 1. Review inventory to determine if there are any unused affected product |
| Quantity | 25,778 |
| Distribution | Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC,SD,TN, TX, VA, WA, WI, and WV; and OUS (foreign) to countries of: Argentina, Australia, Austria, Azerba |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141065 | CONSTELLATION VISION SYSTEM Alcon Research, Ltd., Aug 22, 2014 |
| K233876 | UNITY VCS (8065000296); UNITY CS (8065000297) Alcon Laboratories, Inc., Jun 21, 2024 |
| K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator ( Alcon Laboratories, Inc., Dec 4, 2024 |