MAUDE Adverse Event Report: BAUSCH + LOMB 25 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED AFI&WF; UNIT PHACOEMULSIFICATION

Model Number	BL5425WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned so we are unable to investigate further for root cause.Manufacturing and sterilization records for bl5423wv , lot w9232 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.
Event or Problem Description
The user facility in china reported a vitrectomy cutter was not cutting.
Additional Manufacturer Narrative
The evaluation has been completed.One opened bl5425wv pack from lot w9232 was returned.The expiration date on the label is 2022-sep-12.The pack was expired.The tip protector was in place, as it should be.The needle was not bent.The port window was in the opened position.There was dried solution visible in the tubing.The assembly appeared to be used.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 pc system.The cutter did not cut.There was an air leak in the cutter as there are many bubbles in the aspiration line.We are unable to determine root cause of reported complaint.
Additional Manufacturer Narrative
Correction: d4 udi number.Correction: investigation conclusions: changed 4307 and 192 corrected to 4315.Additional information: the product sample was sent to the vendor for evaluation.The probe was functionally tested and failed the cutting test.There was no apparent actuation of the cutter.The inner diaphragm and associated parts were inspected for possible damage of blockage that could contribute to the lack of actuation of the cutter.Ultimately all the parts were without damage and there was no blockage.The cutter was able to actuate normally upon reassembly.It is unknown what was causing the friction in the cutter that prevented it from moving.The root cause could not be determined.This investigation is complete.

• Brand Name: 25 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED AFI&WF
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 18483568
• Report Number: 0001920664-2024-70008
• Device Sequence Number: 15735253
• Product Code: HQC
• UDI-Device Identifier: 00757770058648
• UDI-Public: (01)00757770058648(17)220912(10)W9232
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2023

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: 09/12/2022
• Device Model Number: BL5425WV
• Device Lot Number: W9232
• 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; 07/09/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 05/10/2024; 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2021
• 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