MAUDE Adverse Event Report: BAUSCH + LOMB 25G BI-B POSTERIOR ELITE W MF; UNIT PHACOEMULSIFICATION

Model Number	SE5425MVB
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the product was not received for evaluation, a review of the photo attached to the complaint file was performed.The original packaging was not visible in the photo.The part number and lot number cannot be verified or determined.The photo clearly shows a (25ga) blue colored esa hub and sleeve assembly in a plastic cup.The sleeve was separated from the hub.There are no close-up photos of the assembly, or the area of separation.It cannot be determined if the assembly was physically damaged before the separation occurred.The cause of the separation cannot be determined by viewing the photo alone.Manufacturing and sterilization records for se5425mvb, lot x5416 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.The facility intends to return the product for evaluation.This investigation is ongoing.
Event or Problem Description
The user facility reported a trocar broke off in the patient's eye.The trocar particle was removed with a forceps.There was no impact to the patient.
Additional Manufacturer Narrative
One blue hub and sleeve assembly and tyvek labeled se5425mvb 25ga., posterior mid-field elite pack, lot x5416 was returned.The expiration date was 2025-may-11.No other contents were returned.Visual inspection found two pieces of the hub and sleeve assembly in a zip lock plastic bag.The valve was on the hub as it should be.Microscopic examination found the sleeve was separated from the hub at the base of the sleeve.In addition, the sleeve was dented and has ridged edges at the location of separation.The hub also has ridged edges at the separated location.Due to the returned opened condition and evidence of use, the cause of the broken hub and sleeve assembly cannot be determined.The product sample was sent to the vendor for their evaluation.This investigation is ongoing.
Additional Manufacturer Narrative
While it cannot be determined what caused the hub assembly to fracture, the incoming inspection records of the 15°25ga esa valve cannula were reviewed and verified to be acceptable.Supplier investigation determined that the issue was not manufacturing related.This investigation is complete.

• Brand Name: 25G BI-B POSTERIOR ELITE W MF
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 19403919
• Report Number: 0001920664-2024-00077
• Device Sequence Number: 17881519
• Product Code: HQC
• UDI-Device Identifier: 00757770059799
• UDI-Public: (01)00757770059799(17)250511(10)X5416
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2024

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 06/10/2024; 07/01/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 06/21/2024; 07/09/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT
• Patient Sex: Unknown