MAUDE Adverse Event Report: BAUSCH + LOMB 25G BI-B COMBINED ELITE W WF; UNIT, PHACOFRAGMENTATION

Model Number	SE5525WVB
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product will not be returned, so therefore unable to investigate the root cause of this event.The manufacturing and sterilization records were reviewed and found to be acceptable.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.
Event or Problem Description
The user facility in the united kingdom reported the cutter stopped cutting.The surgeon released and reapplied the pedal and the cutter restarted for a few seconds and then stop again.This repeated as the surgeon came on and off the pedal.When the cutter stopped it continued to aspirate.This resulted in a prolonged procedure time between 0 and 15 minutes; the exact time was not recorded.No additional anesthesia was required.There was no patient impact.

• Brand Name: 25G BI-B COMBINED ELITE W WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 11575524
• Report Number: 0001920664-2021-00035
• Device Sequence Number: 3621663
• Product Code: HQC
• UDI-Device Identifier: 00757770059768
• UDI-Public: (01)00757770059768(17)220329(10)W8128
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2021

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: 03/29/2022
• Device Model Number: SE5525WVB
• 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: 02/26/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1