MAUDE Adverse Event Report: BAUSCH + LOMB 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)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in china reported that the vitrectomy cutter did not cut during procedure.The cutter continued to aspirate.The surgery was prolonged for 5 minutes.Additional anesthesia was not required.There was no patient impact reported.The patient is currently in good condition.
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.
Additional Manufacturer Narrative
The product is not available for evaluation so we were unable to investigation for root cause.Review of the device history record shows the product was properly made and met all release requirements.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; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INC.; 3365 tree ct. industrial blvd.; st. louis MO 63122
• Manufacturer Contact: juli moore ; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 19551236
• Report Number: 0001920664-2024-00081
• Device Sequence Number: 4850434
• Product Code: HQC
• UDI-Device Identifier: 00757770058549
• UDI-Public: (01)00757770058549(17)250311(10)X5082
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 03/25/2024

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: 03/11/2025
• Device Model Number: BL5523WV
• Device Lot Number: X5082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2023
• 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