MAUDE Adverse Event Report: BAUSCH + LOMB 23GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED AFI & WF; UNIT, PHACOFRAGMENTATION

Model Number	BL5423WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing and sterilization records were reviewed and found to be acceptable.Investigation is ongoing.
Event or Problem Description
It was reported that by the user facility in china that the device failed to perform during a procedure.The vitrectomy cutter in the disposable pack failed to cut the vitreous body normally.Therefore, vitrectomy could not be completed, and it needed to be replaced in order to ensure the safety of the operation.The procedure was extended about 30 minutes and no additional anesthesia was required.No injury or medical intervention was reported.
Additional Manufacturer Narrative
Correction to d4 udi: (b)(4).H4 manufacturer date: from 09-jul-2022 to: 17-aug-2022c the lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.This investigation is ongoing.
Event or Problem Description
The malfunction occurred during the process of cutting the vitreous body.The aspiration continued as normal when the cutting stopped working well.
Additional Manufacturer Narrative
The product was received for evaluation.Visual inspection found the 23ga vitrectomy cutter correctly positioned in the tip protector.The tubing is still coiled and taped together but the aspiration tubing has been disconnected from the collection cassette.The vitrectomy cutter and its tubing are clean and dry and do not appear to have been used.The needle is not bent.The port window is in the opened position.The back cap is 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 pc system.The cutter had good clean cuts throughout the various cut rates and had good aspiration, as it should.Product evaluation showed the returned product performed as intended the complaint could not be duplicated.We will continue to monitor for the reported complaint.No corrective action is required.

• Brand Name: 23GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED AFI & WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd; saint louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 17021882
• Report Number: 0001920664-2023-70053
• Device Sequence Number: 7031477
• Product Code: HQC
• UDI-Device Identifier: 00757770058556
• UDI-Public: (01)00757770058556(17)240108(10)X2376
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101325
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2023

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
• Device Expiration Date: 01/08/2024
• Device Model Number: BL5423WV
• Device Catalogue Number: BL5423WV
• Device Lot Number: X2376
• 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; Not provided
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 07/12/2023; 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• 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
• Patient Sex: Unknown