MAUDE Adverse Event Report: Alcon Research, LLC - Irvine Technology Center CENTURION Vision System; Unit, phacofragmentation

Catalog Number	8065751763
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Intraocular Pressure Decreased (4468)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that an ophthalmic system exhibited with irrigation malfunction which caused chamber to collapse in left eye (os).The procedure was completed the same day with no reports of patient harm.Additional information received indicated that inadequate irrigation was observed during the phacoemulsification phase of cataract surgery, and a system message (sm) was displayed on the device during the procedure.The surgery was initially planned as cataract phacoemulsification; however, due to intraoperative complications, the procedure was converted to an anterior vitrectomy.A three-piece intraocular lens (iol) was implanted, followed by removal of viscoelastic material.Suturing was required to complete the procedure.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION Vision System
• Common Device Name: Unit, phacofragmentation
• Manufacturer (Section D): Alcon Research, LLC - Irvine Technology Center; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): Alcon Research, LLC - Irvine Technology Center; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50373882
• Report Number: 2028159-2026-01320
• Device Sequence Number: 13255660
• Product Code: HQC
• UDI-Device Identifier: 00380657517633
• UDI-Public: (01)00380657517633(17)280329(11)180523(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065751763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Date Device Manufactured: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female