MAUDE Adverse Event Report: BAUSCH + LOMB 27GA OSHIMA VIVID CHANDELIER; ENDOILLUMINATOR

Model Number	56.54.27P
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility in japan reported after surgery, the tip of the probe became curled solid, and could not be pulled out of the incision.An incision was required to pull the probe out of the patients eye.No health problems were observed in the patient.
Additional Manufacturer Narrative
This investigation is on going.
Additional Manufacturer Narrative
This investigation is complete.
Additional Manufacturer Narrative
We received approximately 1-1/2 inches of fiber from the distal end of the probe wrapped in bubble wrap and affixed to a piece of cardboard.This packaging was inside the original, opened product pouch.The cannula and valve were present on the fiber.Visual examination under magnification shows residual surgical matter on the fiber and cannula.The tip of the fiber was no longer conical.The current state has the shape of an irregular, roughly spherical, ball.The diameter of fiber at the distal tip exceeds the od of the cannula.Accumulated debris on the end of the light probe resulted in the concentration of illumination energy exceeding the glass transition temperature of the fiber material.The sterilization and lot history records were reviewed and found to be acceptable.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.
Additional Manufacturer Narrative
Correction: d4 corrected udi number.

• Brand Name: 27GA OSHIMA VIVID CHANDELIER
• Common Device Name: ENDOILLUMINATOR
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): SYNERGETICS; 3845 corporate centre dr.; o'fallon MO 63368
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 16490752
• Report Number: 0001932402-2023-00001
• Device Sequence Number: 12459338
• Product Code: MPA
• UDI-Device Identifier: 20841305107506
• UDI-Public: (01)20841305107506(17)250907(10)M0044836
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 56.54.27P
• Device Catalogue Number: 56.54.27P
• Device Lot Number: M0044836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; 10/04/2024
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 05/04/2023; 06/08/2023; 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALCON CONSTELLATION.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown