MAUDE Adverse Event Report: BAUSCH + LOMB 23GA COMBINED VITRECTOMY PACK W VALVES & AFI & WF; UNIT, PHACOFRAGMENTATION

Model Number	BL5523WVX
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned, so we were unable to do an evaluation.The device history records were reviewed and found 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 is required.The investigation is complete.
Event or Problem Description
The user facility in (b)(6) reported the cutter stopped working spontaneously.When the cutter stopped cutting the aspiration continue slowly.There was no medical intervention required, no impact or injury to the patient, no need for surgery to be prolonged, and no additional anesthesia was needed.The surgery was completed with the replacement of a new pack.

• Brand Name: 23GA COMBINED VITRECTOMY PACK W VALVES & AFI & WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 12025617
• Report Number: 0001920664-2021-00073
• Device Sequence Number: 1376121
• Product Code: HQC
• UDI-Device Identifier: 00757770059119
• UDI-Public: (01)00757770059119(17)220110(10)W7659
• Combination Product (Y/N): Y
• Initial Reporter Country: MY
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2021

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: 01/10/2022
• Device Model Number: BL5523WVX
• Device Catalogue Number: BL5523WVX
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1