MAUDE Adverse Event Report: BAUSCH + LOMB, INC 23G BI-B COMBINED ELITE W WF; UNIT, PHACOFRAGMENTATION

Model Number	SE5523WVB
Medical Device Problem Codes	Suction Problem (2170); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device return has been requested, and has not been received.The lot number is unknown.The device history record review cannot be performed at this time.The investigation is underway.
Event or Problem Description
The user facility in the united kingdom reports that they were performing a macular hole repair.The foot pedal was being used and the trocars were inserted.The phaco/vr machine started to make a strange noise.It was further explained that the irrigation was working but the aspiration was not.All connecting tubing was tightened and the vitrectomy packs were changed to no avail.Surgery was abandoned.There was no patient impact; no medical intervention reported.
Additional Manufacturer Narrative
Product evaluation could not be performed as the complaint unit was not returned.The most probable root cause is unknown/inconclusive.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action was required.The investigation is complete.

• Brand Name: 23G BI-B COMBINED ELITE W WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC; 4100 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 20299968
• Report Number: 0001920664-2024-00118
• Device Sequence Number: 18078848
• Product Code: HQC
• UDI-Device Identifier: 00757770059959
• UDI-Public: (01)00757770059959
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SE5523WVB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS SYSTEM AND ACCESSORIES.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown