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
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.
Event or Problem Description
Additional information was received that the original surgery was a scheduled vitrectomy for a macular hole.

• 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: 16009291
• Report Number: 0001932402-2022-00005
• Device Sequence Number: 14830453
• 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; 04/12/2023
• 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