MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS 23G VITRECTOMY CUTTER; UNIT, PHACOFRAGMENTATION

Model Number	BL5623
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This event was reported to china national medical device adverse events reporting system by the user facility.The vitrectomy cutter couldn¿t get up to speed during vitrectomy.It was found that the vitrectomy cutter could not reach the cutting speed, and it was replaced with a new instrument to ensure that the treatment continued normally.
Additional Manufacturer Narrative
Manufacturing and sterilization records were reviewed and found to be acceptable.Investigation is ongoing.
Additional Manufacturer Narrative
The product was not returned, and no further information has been provided.Therefore, we are unable to investigate further for root cause.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action is required.

• Brand Name: STELLARIS 23G VITRECTOMY CUTTER
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd; saint louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 18324570
• Report Number: 0001920664-2023-70137
• Device Sequence Number: 7437906
• Product Code: HQC
• UDI-Device Identifier: 20757770057911
• UDI-Public: (01)20757770057911(17)240823(10)X3861
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2023

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: 08/23/2024
• Device Model Number: BL5623
• Device Lot Number: X3861
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2023
• 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 UNIT AND ACCESSORIED
• Patient Age: 72 YR
• Patient Sex: Female