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

Model Number	SE5525WVB
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility in the united kingdom reported that 2 trocars from the stellaris elite 25g pack separated after postoperative removal from the patient.One was noticed by the nurse when the surgeon handed the trocar back after removal from the patient and the other was seen separating as the surgeon was taking the trocar out of the patient eye.It was reported there was no impact to the patient and no medical intervention required.
Additional Manufacturer Narrative
The trocars have not been returned for evaluation.The device history record (dhr) review did not find any non-conformities or anomalies related to this event.The investigation is ongoing.
Additional Manufacturer Narrative
Correction: h10: the product was not returned for evaluation.Therefore, the root cause could not be determined.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.The investigation is complete.
Additional Manufacturer Narrative
Udi related data quality updates only.The udi-di is being provided.Although requested, the lot number was not provided, therefore the udi-pi is not available.

• Brand Name: 25G BI-B POSTERIOR ELITE W WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial bvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial bvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 18371691
• Report Number: 0001920664-2023-70150
• Device Sequence Number: 20737332
• Product Code: HQC
• UDI-Device Identifier: 00757770059768
• UDI-Public: (01)00757770059768
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2023

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: SE5525WVB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 02/05/2024; 10/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown