MAUDE Adverse Event Report: BAUSCH + LOMB 25 GA. BI-BLADE CUTTER STELLARIS ELITE PACK; UNIT, PHACOFRAGMENTATION

Model Number SE5425WVB

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The user facility in france reported that a vitreotome had a malfunctioning guillotine.There was no impact to the patient and no medical intervention was required.

Manufacturer Narrative

Per the user facility, the product is not available for evaluation.Review of the device history records shows product was properly manufactured and met all release requirements.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.

Manufacturer Narrative

One opened pack was returned.Visual inspection found the needle bent, the port window in the opened position and dried solution on the cutter needle.The cutter looks used with fluid in the lines.The back cap is aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected and no damage was found.A functional test was performed using a stellaris elite system.The cutter did not cut.The inner needle is binding up, preventing cutting and aspiration.It should be noted that a bent needle could contribute to poor cutting performance due to friction and binding between the inner and out needle assemblies.Due to the returned condition, and evidence of use, the root cause of the bent needle which can contribute to poor cutting could not be determined.We will continue to monitor for the reported complaint.

• Brand Name: 25 GA. BI-BLADE CUTTER STELLARIS ELITE PACK
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd; saint louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 17975849
• MDR Text Key: 326240967
• Report Number: 0001920664-2023-70113
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00757770059775
• UDI-Public: (01)00757770059775(17)240920(10)X4036
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2023

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
• Device Operator: Health Professional
• Device Model Number: SE5425WVB
• Device Lot Number: X4036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2023
• 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: STELLARIS UNIT AND ACCESSARIES