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

Model Number	BL5423WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing and sterilization records for bl5423wv, lot x4408 were reviewed and found to be acceptable.This investigation is ongoing.
Event or Problem Description
The user facility in china reported the vitrectomy cutter was not cutting when during surgery; however, aspiration continued.There was no patient injury.
Additional Manufacturer Narrative
Correction: d4 updated udi number.Additional information: no other complaints were noted for cutting problems in lot x4408.The root cause of this complaint could not be determined as the complaint unit was not available for analysis.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
The product evaluation has been completed.One opened bl5423wv pack from lot x4408 was returned.The expiration date on the label is 2024-nov-14.The 23ga vitrectomy cutter was lying loose on the top of the pack components.The tip protector was returned, but was not on the cutter.The needle was not bent.The port window was in the opened position.The tubing and needle was clean and dry.The tubing on the collection cassette was also clean and dry.The assembly does not appeared to have been used, though the components had been repacked and the tubing was not coiled as originally manufactured.The back cap on the vitrectomy cutter 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 had good clean cuts throughout the various cut rates and aspirated as intended.The root cause of this complaint could not be determined as the returned device was operating as expected.The reported problem was not duplicated.This investigation is complete.
Additional Manufacturer Narrative
Corrections: investigation findings 1.Investigation conclusions 1.The root cause of this complaint could not be determined as the complaint unit was not available for analysis.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.

• Brand Name: 23 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; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 19948258
• Report Number: 0001920664-2024-00098
• Device Sequence Number: 7207964
• Product Code: HQC
• UDI-Device Identifier: 00757770058556
• UDI-Public: (01)00757770058556(17)241114(10)X4408
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 06/25/2024

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: 11/14/2024
• Device Model Number: BL5423WV
• Device Lot Number: X4408
• 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: 07/17/2024
• Supplement Date Received by Manufacturer: 08/26/2024; 10/02/2024; 10/11/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/09/2024; 10/02/2024; 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• 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
• Patient Sex: Unknown