MAUDE Adverse Event Report: BAUSCH + LOMB 25 GA HIGH SPEED VITRECTOMY CUTTER; UNIT, PHACOFRAGMENTATION

Model Number	BL5625
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This event was reported to china national medical device adverse events reporting system by a user facility in china.During the vitrectomy with the ophthalmic treatment system, it was found that the vitrectomy cutter didn''t cut.The machine was immediately replaced and the treatment continued.There was no patient injury.
Additional Manufacturer Narrative
The device is not available for evaluation.The investigation is ongoing.
Additional Manufacturer Narrative
The product was not returned for investigation.Therefore, the root cause could not be determined.Review of the device history record (dhr) shows 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.Based on all complaint information and investigation activities completed, no corrective action is required.The investigation is complete.

• Brand Name: 25 GA HIGH SPEED VITRECTOMY CUTTER
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 18247905
• Report Number: 0001920664-2023-70132
• Device Sequence Number: 12433753
• Product Code: HQC
• UDI-Device Identifier: 20757770057928
• UDI-Public: (01)20757770057928(17)190805
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

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: 09/19/2024
• Device Model Number: BL5625
• Device Lot Number: X4021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2023
• 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 Age: 65 YR
• Patient Sex: Male