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

Model Number	SE5423WVB
Medical Device Problem Codes	Fluid/Blood Leak (1250); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history was reviewed and found to meet manufacturing specification.The products are not available for evaluation.The investigation is ongoing.
Event or Problem Description
The user facility in (b)(6) reported the valves on the trocars did not close properly.When the instrument was removed, the trocars also came out and had to be placed again.This occurred on three occasions for the same surgery.Serum also leaked through the valves.The surgeries were prolonged for approximately 15 minutes and sutures were not necessary for all surgeries but were frequently used.All surgeries were completed successfully with no patient impact.
Additional Manufacturer Narrative
The product is not available for return.Therefore, we are unable to determine the root cause.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.

• 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 INCORPORATED; 3365 tree ct. industrial blvd; saint louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 14915791
• Report Number: 0001920664-2022-00090
• Device Sequence Number: 16651991
• Product Code: HQC
• UDI-Device Identifier: 00757770059935
• UDI-Public: (01)00757770059935
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 06/10/2022

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
• Device Expiration Date: 03/07/2022
• Device Model Number: SE5423WVB
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown