MAUDE Adverse Event Report: Bausch + Lomb 25 Directional Laser Probe; Unit, Phacofragmentation

Model Number	55.26.25
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction

• Brand Name: 25 Directional Laser Probe
• Common Device Name: Unit, Phacofragmentation
• Manufacturer (Section D): Bausch + Lomb; 3845 corporate centre drive; rochester NY 14609
• Manufacturer (Section G): Synergetics, Inc; 3845 corporatecentre drive; o'fallon MO 63368
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd; st. louis, MO 63122 ; +1(636)226-3089
• MDR Report Key: 50087423
• Report Number: 0001932402-2026-00001
• Device Sequence Number: 16020190
• Product Code: HQB
• UDI-Device Identifier: 20841305106790
• UDI-Public: (01)20841305106790(17)281013(11)251014(10)M0061911
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K952586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: Health Professional
• Device Model Number: 55.26.25
• Device Lot Number: M0061911
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/25/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown