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

Model Number	BL2282
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Codes	Eye Injury (1845); Intraocular Pressure Increased (1937); Prolapse (2475)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A field service engineer was dispatched to the user facility to evaluate the system.He was unable to find any faults.All function¿s of the system performed as they should.The device history was reviewed and showed the module met all specifications on the date of manufacture.The investigation is underway.
Event or Problem Description
It was reported by the user facility in the united kingdom that during the case the eye became hard due to high pressure causing the iris to prolapse.When checked the infusion pressure was set to 35mmhg.The iris was redeposited successfully and the anterior chamber reformed.Surgery was completed safely, but the iop fluctuations did compromise the corneal view to some extent making the later stages of the membrane peel more challenging.I wasn¿t timing the surgery, but the vitrectomy cutter is inefficient and the gel trimming took longer than it should have.A small volume of anesthesia top-up was needed.Apart from a slightly dilated pupil, even following miochol-e, the eye is quiet with a normal iop.
Additional Manufacturer Narrative
The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action is required.Product evaluation did not confirm the failure and we are unable to determine the root cause.No corrective action required.

• Brand Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): ST. LOUIS; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; 6362263220
• MDR Report Key: 17839341
• Report Number: 0001920664-2023-70093
• Device Sequence Number: 20757086
• Product Code: HQC
• UDI-Device Identifier: 00757770497836
• UDI-Public: (01)00757770497836(17)240811
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101325
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2023

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 Model Number: BL2282
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2011
• 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
• Patient Sex: Unknown