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

Model Number	SE5425WVB
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing and sterilization records for se5425wvb, lot w7983 were reviewed and found to be acceptable.Additional information regarding patient impact has been requested.The investigation is ongoing.(b)(6).
Event or Problem Description
The user facility in (b)(6) reports the vitrectomy cutter did not work.The stellaris cassette was changed.Patient impact has been requested.
Additional Manufacturer Narrative
The device has not been returned for evaluation.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 necessary.Upon device return the investigation will be reopened.
Additional Manufacturer Narrative
Upon further investigation, we found there was no patient contact.The information provided does not suggest this incident may have caused or contributed to a death, serious injury or a serious deterioration in state of health.This event is no longer deemed reportable.

• Brand Name: 25G BI-B POSTERIOR ELITE W WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 11574886
• Report Number: 0001920664-2021-00032
• Device Sequence Number: 17009420
• Product Code: HQC
• UDI-Device Identifier: 00757770059775
• UDI-Public: (01)00757770059775(17)220306(10)W7983
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2021

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: 03/06/2022
• Device Model Number: SE5425WVB
• Device Lot Number: 222
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 04/16/2021; 05/12/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 05/10/2021; 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS SYSTEM AND ACCESSORIES