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
The manufacturing and sterilization records for bl5423wv, lot x2712 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.
Additional Manufacturer Narrative
The product evaluation has been completed.One opened (b)(6) pack from lot x2712 was returned.The tip protector was not returned.The cutter was lying loose in the pack tray under the other pack components.The needle was bent.The port window was in the opened position.There was fluid in the tubing.The back cap was aligned correctly with the vent holes in the side of the cutter.The connectors were inspected and no damage was found.However, the tubing was disconnected at approximately 9 inches from the back of the cutter.After reconnecting the tubing, a functional test was performed using a stellaris pc system.The cutter will not cut.The inner needle was binding up and not reaching the cutting edge.In addition, there was an unknown, clear, thick substance in the tubing which was not allowing the fluid to pass through.Due to evidence of use, the cause of the bent needle cannot be determined.Due to the dirty, damaged condition in which the product was returned it was not possible to determine the root cause of the bent needle.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
Correction: investigation findings and investigation conclusions codes have been corrected.
Additional Manufacturer Narrative
Upon further investigation, we found there was no patient contact.The information provided does not suggest this incident may have caused or contributed to a death, serious injury or a serious deterioration in state of health.This event is no longer deemed reportable.
Additional Manufacturer Narrative
Correction: d1.

• 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, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 18425322
• Report Number: 0001920664-2024-70001
• Device Sequence Number: 15481024
• Product Code: HQC
• UDI-Device Identifier: 00757770058556
• UDI-Public: (01)00757770058556(17)240304
• 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,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: 03/04/2024
• Device Model Number: BL5423WV
• Device Lot Number: X2712
• 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; Not provided; Not provided
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 02/05/2024; 02/05/2024; 02/28/2024; 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT.
• Patient Sex: Unknown