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

Model Number	SE5425WVB
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing, sterilization and lot history records were reviewed and found to be acceptable.The product has been requested for evaluation.The investigation is ongoing.
Event or Problem Description
The user facility in (b)(6) reported the cutter did not cut and had to be exchanged intraoperatively.It was noticed at the beginning of the procedure the material that was supposed to be aspirated had not been removed; however, aspiration continued.The procedure was extended by 2 minutes 30 seconds and was completed successfully with no additional anesthesia required.There was no impact to the patient.
Additional Manufacturer Narrative
The product has not been returned for evaluation.A supplemental report will be submitted if any additional information is received.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.
Additional Manufacturer Narrative
One opened se5425wvb pack from lot w8137 was returned for evaluation.The cutter was returned in the tip protector and prime cup.The needle was bent and the port window was in the opened position.There was dried solution in the tubing.The back cap was aligned correctly with the vent hole 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 did not cut.There was air leaking while performing the functional test and air was coming out of the vent holes.The product was sent to the vendor for further evaluation.This investigation is ongoing.
Additional Manufacturer Narrative
An evaluation has been completed by the vendor.It was noticed that the needle was bent and a tear in the diaphragm was observed which could have caused the leak.Probes are 100% tested for diaphragm leaks at a pressure higher than normal operation which would usually cause a detectable failure indicating there is a weak spot.The incident of a failure after being tested is unusual however could occur.The most probable root cause is a manufacturing defect, however the exact root cause of the tear cannot be determined.Manufacturing and sterilization records were reviewed and found to be acceptable.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.

• 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; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 treecourt industrial blvd; st. louis, MO 63122
• MDR Report Key: 11793519
• Report Number: 0001920664-2021-00054
• Device Sequence Number: 14503977
• Product Code: HQC
• UDI-Device Identifier: 00757770059775
• UDI-Public: (01)00757770059775
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/19/2021

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: 03/29/2022
• Device Model Number: SE5425WVB
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/09/2021; 12/09/2021; 04/19/2022
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 07/07/2021; 01/04/2022; 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2020
• 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
• Patient Sex: Unknown