MAUDE Adverse Event Report: BAUSCH + LOMB, INC. 23GA COMB PK W V&AFI&WF; UNIT, PHACOFRAGMENTATION

Model Number	BL5523WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not been returned despite multiple requests.Manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is ongoing.
Event or Problem Description
The user facility in china reports a cutting problem during a procedure in which the doctor found the vitrectomy cutter was "breathing" out when used.It is not known if cutting stopped and aspiration continued.No patient impact was reported.
Additional Manufacturer Narrative
Additional information: aspiration continued.There was no medical intervention.Visual inspection found the vitrectomy cutter loose in the pack tray, but with the tubing neatly coiled and the extension handle assembled onto the back of the cutter body.There is a small amount of fluid visible in the aspiration line, and the needle is bent.The port window is in the opened position, and the ack cap is correctly positioned with the vent holes on the body of the cutter.The connectors were inspected and no damage was found.A functional test was performed using a stellaris pc system.Air was flowing out the port window causing bubbles in the beaker of water.Further inspection found that the aspiration line and the air-infusion line are reversed.The assembly cannot function properly in this condition.Due to fluid in the aspiration line (evidence of use), the cause of the reversed tubing cannot be determined.This sample will be sent to the vendor for investigation.The investigation is ongoing.
Event or Problem Description
Aspiration continued.There was no medical intervention.
Additional Manufacturer Narrative
The vendor found a slight bend in the needle, misaligned cutter, and a crack along the edge of the probe body with a loose cap on the probe.Due to the probe's limitations from visual inspection, the functional tests could not be completed.When the operator tried to put the tubing on, the cap popped off.Operator could not proceed with functional test.The reported issue could not be duplicated.The most probable is unknown/inconclusive.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 investigation is complete.

• Brand Name: 23GA COMB PK W V&AFI&WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC.; 1400 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 18371145
• Report Number: 0001920664-2023-70144
• Device Sequence Number: 7579925
• Product Code: HQC
• UDI-Device Identifier: 00757770058549
• UDI-Public: (01)00757770058549(17)241107(10)X4358
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/07/2024
• Device Model Number: BL5523WV
• Device Lot Number: X4358
• 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: 12/21/2023
• Supplement Report FDA Received Date: 02/05/2024; 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2023
• 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 SYSTEM AND ACCESSORIES
• Patient Sex: Unknown