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

Model Number	BL14304
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Codes	Corneal Edema (1791); Intraocular Infection (1933); Capsular Bag Tear (2639)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The system has been used after the event without incidents.The investigation is ongoing.
Event or Problem Description
The user facility in france reported that during the fragmentation phase, without audible alert, the phacoemulsifier switched to max suction mode with rupture.The suction triggered on its own when the surgeon had operated at the bottom of the groove, and without warning.The patient experienced edema/inflammation and a vitrectomy was impossible due to local anesthesia.The patient's best corrected visual acuity is 1/20.
Additional Manufacturer Narrative
The field service technician on site reported this is applicative problem and not equipment problem, other surgeons use stellaris without problem.Suspected isolated cassette malfunction affecting vacuum control or a momentary software/configuration glitch.User-specific factors may have contributed, as the surgeon was relatively inexperienced.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.
Event or Problem Description
Additional information: the surgeon indicates she doesn't have enough experience yet, but here are a few points to consider: during surgery of (b)(6) 2025, the 3 parts iol was inserted in the sulcus despite in the capsular bag as planned.Currently the patient presents with inflammation with ongoing treatment.Va was 2/10 which increased to 7/10 but it was not final as the patient presents a risk of retinal detachment.Additional medical intervention was anterior vitrectomy.No further information provided.

• Brand Name: STELLARIS ELITE VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 6362263089
• MDR Report Key: 21752066
• Report Number: 0001920664-2025-00034
• Device Sequence Number: 8200022
• Product Code: HQC
• UDI-Device Identifier: 00757770520251
• UDI-Public: (01)00757770520251
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170052
• 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
• Report Date (Section B): 03/12/2025

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: BL14304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown