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

Model Number	BL11145
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Corneal Clouding/Hazing (1878)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After the event, a service engineer performed user tests and service calibration procedure of the complete foot control.The foot control was working properly and the system was ready for use.A review of the device history record found no non conformities or anomalies related to this event.The investigation is ongoing.No remedial, corrective, preventive or field safety corrective action is required.
Event or Problem Description
On 27-jan-2025, additional information was received which changed the reportability decision of this event assessing it as reportable.The user facility in belgium reported a problem with the foot control function.There was no indication that the issue had an adverse effect on the patient.It was later reported that the foot control failed to function properly during the procedure.Several attempts were made to resolve the problem, but none were effective.Another device was brought in to continue the surgery, however, the cornea had become cloudy due to the delay and it was no longer possible to operate safely.The cornea was treated with medication and the procedure was completed five days later at another hospital after the cornea had sufficiently cleared.At a follow -up check approximately two months later, the patient was found to have 9/10 vision in that eye.The patient subsequently developed ¿irvin glass¿ or fluid at the height of the cornea which is a known consequence of surgery that takes place weeks or months after ophthalmic surgery.The current status of the patient was not provided.
Additional Manufacturer Narrative
Added: d9 and h3.Product evaluation did not confirm the failure mode.Issue could not be reproduced, and no replacement was provided.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.No corrective action required.

• Brand Name: STELLARIS ELITE VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 21395532
• Report Number: 0001920664-2025-00011
• Device Sequence Number: 18239652
• Product Code: HQC
• UDI-Device Identifier: 00757770524495
• UDI-Public: (01)00757770524495(11)191001
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 04/12/2023

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
• Operator of Device: Health Professional
• Device Model Number: BL11145
• 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: 01/27/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• 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