Brand Name: Alcon Laboratories — Class II medical device recall Z-2109-2025
Ongoing recall by Alcon Research LLC, reported 2025-07-16, distributed nationwide. Due to the potential that some units within specific lots were damaged during the manufacturing process. The a
| Recall number | Z-2109-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research LLC, Fort Worth, TX, United States |
| Recall initiated | 2025-04-28 |
| Classified | 2025-07-10 |
| Reported by FDA | 2025-07-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BG, BH, BR, BS, CA, CH, CL, CN, CO, CR, CY, DE, EC, ES, FI, FR, GB, GT, HK, HR, HU, ID, IE, IL, IN, IR, IS, IT, JM, JP, KE, KR, KW, LB, LK, LU, LV, MA, MT, MX, MY, NL, NZ, OM, PE, PH, PK, PL, QA, RS, SA, SE, SG, SI, SV, TH, TN, TR, TW, UA, UY, VN, ZA |
| Quantity | 89,495 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00380657510580, 00380657510771, 00380657511556, 00380657516131, 00380657516179, 00380657517152, 00380657517657, 00380657517671, 00380657518654, 00380657524488 |
| Lot numbers | 1754MX, 1754T1, 175M41, 1762K1, 1762K7, 1762K8, 1762KD, 176CC8, 176CC9, 176CCA, 176CCD, 176WTW, 176WU5, 176WU6, 17769P, 17769R, 177TVD, 1782FY, 1782H0, 1782H1, 1782HA, 1782HC, 1782HD, 1782HE, 1782HJ, 1782HL, 1782J3, 1782J4, 178D4X, 178D4Y, 178D51, 178D52, 178D54, 178D56, 178D58, 178DE4, 178DE6, 178DE7, 178DEH, 178RYU and 72 more |
| Model numbers | 8065751058, 8065751077, 8065751155, 8065751613, 8065751617, 8065751715, 8065751765, 8065751767, 8065751865, 8065752448 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2109-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.