MAUDE Adverse Event Report: BAUSCH + LOMB 25GA HIGH-FLOW I.I.C.; ENDOILLUMINATOR

Model Number	56.34.25P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the user facility had a microscopic glass part fall onto the posterior segment on the retina.The surgeon removed the lens with a 25g vitrector.
Additional Manufacturer Narrative
Product is not able to be returned as it was discarded.The investigation is ongoing.
Additional Manufacturer Narrative
Additional information, d4.
Additional Manufacturer Narrative
A review of the device history record (dhr) did not find any non-conformities or anomalies related to the reported event.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be determined.

• Brand Name: 25GA HIGH-FLOW I.I.C.
• Common Device Name: ENDOILLUMINATOR
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): SYNERGETICS; 3845 corporate centre dr.; st. louis MO 63368
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 636226-3187
• MDR Report Key: 16009326
• Report Number: 0001932402-2022-00006
• Device Sequence Number: 20275404
• Product Code: MPA
• UDI-Device Identifier: 20841305107438
• UDI-Public: (01)20841305107438(17)250812
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K952586
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2022

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: 08/11/2025
• Device Model Number: 56.34.25P
• Device Catalogue Number: 56.34.25P
• Device Lot Number: M0044445
• 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; Not provided
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 02/08/2023; 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown