MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS PC VISION ENHANCEMENT SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number BL2282

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Retinal Injury (2048)

Event Date 07/14/2023

Event Type  Injury  

Manufacturer Narrative

The field service technician on site has replaced the air pump, and the device is now in normal operation.This investigation is ongoing.

Event Description

The user facility in china reported surgery for vitreous hemorrhage in the left eye, combined vitreoretinal surgery in the left eye was performed under local anesthesia.Preoperative test results of the equipment were normal, and gas-liquid exchange and silicone oil filling could not be performed after intraoperative vitreous cavity resection.The patient remains to be observed after surgery.

Manufacturer Narrative

The pump was retained by the hospital; therefore, it will not be returned for evaluation.The device history was reviewed and found to meet manufacturing specification.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.This investigation is complete.

• Brand Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 17563676
• MDR Text Key: 321321484
• Report Number: 0001920664-2023-70080
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00757770524532
• UDI-Public: (01)00757770524532(11)190903
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K101325
• 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
• Report Date: 07/24/2023

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
• Device Operator: Health Professional
• Device Model Number: BL2282
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female