MAUDE Adverse Event Report: ALCON LABORATORIES, INC. ALCON; UNIT, PHACOFRAGMENTATION

Model Number	8065752200
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Plastic tubing connection wouldn't come apart after prime.

• Brand Name: ALCON
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway (r9-2); fort worth TX 76134
• MDR Report Key: 25428749
• Report Number: 25428749
• Device Sequence Number: 10284384
• Product Code: HQC
• UDI-Device Identifier: 00380657522002
• UDI-Public: (01)00380657522002
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2026
• Report Date (Section F): 05/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 8065752200
• Device Catalogue Number: 8065752200
• Device Lot Number: 17XPU7
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 06/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/22/2026