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

Model Number	SE5523WVB
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been requested for return.Manufacturing and sterilization records for this device were reviewed and found to be acceptable.The investigation is underway.
Event or Problem Description
A user facility in the united kingdom reported that the device did not cut during the vitrectomy procedure, however, aspiration continued.The device was replaced and surgery was completed with no reported patient impact.
Additional Manufacturer Narrative
The device was returned and evaluated.The evaluation revealed the needle is bent/curved and there was fluid in the aspiration tubing.The back cap was aligned correctly with the vent holes in the side of the cutter body.The connectors were inspected and no damage was found, however the connector that is 9 inches from the back of the cutter is loose, but not disconnected.Functional testing was performed and the needle did not move and would not cut, the aspiration did continue to work.The bent needle could contribute to the poor cutting performance however the needle was returned without the tip protection and sticking out of a plastic bag, thus the cause of the bent needle 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: 23G BI-B COMBINED ELITE W WF
• Common Device Name: UNIT PHACOEMULSIFICATION
• 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: 19939774
• Report Number: 0001920664-2024-00100
• Device Sequence Number: 12595620
• Product Code: HQC
• UDI-Device Identifier: 10757770059956
• UDI-Public: (01)10757770059956(17)250728(10)X5782
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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: 07/28/2025
• Device Model Number: SE5523WVB
• Device Lot Number: X5782
• 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: 07/11/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS SYSTEM AND ACCESSORIES
• Patient Sex: Unknown