MAUDE Adverse Event Report: BAUSCH + LOMB 25G BI-B COMBINED ELITE W WF; UNIT, PHACOFRAGMENTATION

Model Number	SE5625B
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility in japan reported that the vitrectomy cutter did not move well and aspiration continued.The procedure was completed with a second device with no patient injury.
Additional Manufacturer Narrative
Product has been requested but not received.A review of the device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.The investigation is ongoing.
Additional Manufacturer Narrative
The product was returned and evaluated.The tip protector was returned, however not on the cutter.The needle was observed to be bent.The connectors were inspected and no damage was found.A functional test was performed and the cutter did not cut properly, the inner needle was binding up and moved intermittently.The port window remained in the open position when the inner needle bound up which allowed the vacuum to continue.The bent needle could contribute to poor cutting performance.Due to evidence of use and the returned condition with the tip protector loose in the container and not on the cutter, the cause of the bent needle cannot be determined.A review of the device history record (dhr) did not find any non-conformities or anomalies related to the reported event.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.

• Brand Name: 25G BI-B COMBINED ELITE W WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 treecourt industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 20063322
• Report Number: 0001920664-2024-00104
• Device Sequence Number: 18088806
• Product Code: HQC
• UDI-Device Identifier: 00757770059768
• UDI-Public: (01)00757770059768(17)250602(10)X5494
• Combination Product (Y/N): N
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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 Expiration Date: 06/02/2025
• Device Model Number: SE5625B
• Device Lot Number: X5494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2024
• 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