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

Model Number 56.54.27P

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/06/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

This investigation is on going.

Manufacturer Narrative

This investigation is complete.

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.

• Brand Name: 27GA OSHIMA VIVID CHANDELIER
• Type of Device: 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
• MDR Text Key: 310777370
• Report Number: 0001932402-2023-00001
• Device Sequence Number: 1
• Product Code: MPA
• UDI-Device Identifier: 20841305107506
• UDI-Public: (01)20841305107506(17)250907
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K952586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALCON CONSTELLATION
• Patient Outcome(s): Required Intervention