MAUDE Adverse Event Report: BAUSCH + LOMB 25G BI-B COMBINED ELITE W WF; UNIT, PHACOFRAGMENTATION

Model Number SE5525WVB

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Hyphema (1911)

Event Type  Injury  

Manufacturer Narrative

The product has been requested.Manufacturing and sterilization records were reviewed and found to be acceptable.This investigation is ongoing.

Event Description

It was reported by the user facility in the united kingdom that the infusion line was not retaining in the trocar and led to a hemorrhage.Surgery was extended 15-30 minutes for additional treatment.

Manufacturer Narrative

As new information has been reported the event is no longer deemed to be a serious injury as the hemorrhage was very small and is very often a complication during vitreoretinal surgery.This event no longer meets reportability requirements.

Event Description

Additional information received the user facility reports that they just put bottle height up to control the hemorrhage.No additional anasthesia was required and followup on the patient is good the hemorrhage did not spread.

• Brand Name: 25G BI-B COMBINED ELITE W WF
• 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: 19003720
• MDR Text Key: 338904870
• Report Number: 0001920664-2024-00045
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00757770059768
• UDI-Public: (01)00757770059768(17)250101(10)X4666
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SE5525WVB
• Device Lot Number: X4666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2023
• 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.
• Patient Outcome(s): Other