MAUDE Adverse Event Report: BAUSCH + LOMB INC. 25 GA. BI-BLADE VITREOUS CUTTER POSTERIOR MID-FIELD STELLARIS ELITE PACK; UNIT, PHACOFRAGMENTATION

Model Number	SE5425MVB
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility in france reported that during surgery a vitrectomy cutter stopped cutting and aspiration continued.There was no reported patient consequence or impact.
Additional Manufacturer Narrative
The device was returned and evaluated.The evaluation revealed the assembly was dirty with fluid in the lines, the vitrectomy cutter tip protector was not returned.The needle was not bent, however debris was visible around the port opening on the outer needle shaft.The female lure fitting connector on the cutter was aspiration tube was broken.A functional testing could not be performed on the assembly, however due to fluid in the tubes it can be concluded it worked at one time.A functional testing was performed with the cutter and the cutter had clean cuts and aspirated as intended.Due to the condition of the device return a conclusion could not be determined.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on all available information, no causal factors can be determined and no conclusion can be drawn.The investigation is complete.

• Brand Name: 25 GA. BI-BLADE VITREOUS CUTTER POSTERIOR MID-FIELD STELLARIS ELITE PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB INC.; 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: 20587310
• Report Number: 0001920664-2024-00143
• Device Sequence Number: 20472564
• Product Code: HQC
• UDI-Device Identifier: 10757770059796
• UDI-Public: (01)10757770059796(17)250511(10)X5416
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

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: 05/11/2025
• Device Model Number: SE5425MVB
• Device Lot Number: X5416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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