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	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.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.This investigation is ongoing.
Event or Problem Description
The user facility in italy reported the vitreous cutter was not working and made a vent-like noise when the doctor activated the cut.
Additional Manufacturer Narrative
Correction to d4 udi: from(b)(6)to (b)(6) the product was not returned for evaluation.Based on the available information, the root cause of this event could not be determined.Complaints of this nature will continue to be monitored.
Additional Manufacturer Narrative
The product was returned.Visual inspection found the tip protector was not returned and the needle is bent/curved.There is dried solution in the aspiration tubing and the assembly looks used.The back cap is aligned correctly with the vent holes in the side of the cutter body.The connectors were inspected, and no damage was found.A functional test was performed using a stellaris elite system.The cutter has an internal air leak which expels air out the back cap vent hole.This cutter cannot function properly in this condition.Due to the returned condition and evidence of use, the cause of the bent needle cannot be determined.The product was sent to the vendor for further evaluation.This investigation is ongoing.
Additional Manufacturer Narrative
The vendor evaluation confirmed leakage of air in the vent holes of the cap.Measurements were taken of the cap and o-ring.The o-ring was with in specification.The cap had an id larger than specified for the size of the o-ring which caused a loose fit between the o-ring and the inner cutter assembly resulting in the leak.The most probable root cause was determined to be the cap was not within specification.This is determined to be an isolated incident, and no corrective action is required.

• Brand Name: 23G BI-B COMBINED ELITE W WF
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 6362263089
• MDR Report Key: 18799733
• Report Number: 0001920664-2024-70033
• Device Sequence Number: 17921129
• Product Code: HQC
• UDI-Device Identifier: 10757770059956
• UDI-Public: (01)10757770059956(17)240808(10)X3740
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup,Followup,Followup
• Report Date (Section B): 02/07/2024

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: 08/08/2024
• Device Model Number: SE5523WVB
• Device Lot Number: X3740
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; 02/25/2025; 04/22/2025
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 04/16/2024; 03/11/2025; 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT.
• Patient Sex: Unknown