MAUDE Adverse Event Report: BAUSCH + LOMB, INC STELLARIS ELITE ADAPTIVE FLUIDICS BASIC PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL5115-4
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	02/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is ongoing.
Event or Problem Description
A user facility reports an iris burn due to an irrigation issue that occurred while experiencing a tubing malfunction.No additional anesthesia or medication was necessary, but there was slight inflammation and the surgeon placed a stitch and patched the eye until the next day.The patient is okay.Post op vision was 20/40.
Additional Manufacturer Narrative
The product was returned in a plastic bag.The tubing with spike was connected to the bss bottle have been used.A functional test was performed using a stellaris elite system.The bss bottle was drained in the cassette during the functional test.The assembly primed, irrigated and aspirated as intended.In addition, the irrigation flow was challenged using three methods of control - the touch screen on/off switch, the foot controller on/off switch and the pinch clamp on the tubing.The irrigation started and stopped when prompted by all three methods.The returned product while used and dirty, performed as intended during functional testing, giving no indication that would support any condition that would lead to the reported complaint for a burn.The root cause is unknown/inconclusive since the reported problem could not be reproduced.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.The investigation is complete.

• Brand Name: STELLARIS ELITE ADAPTIVE FLUIDICS BASIC PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122
• MDR Report Key: 13685873
• Report Number: 0001920664-2022-00037
• Device Sequence Number: 20126317
• Product Code: HQC
• UDI-Device Identifier: 00757770058877
• UDI-Public: (01)00757770058877(17)230612
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2022

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 Expiration Date: 06/12/2023
• Device Model Number: BL5115-4
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BSS
• Patient Sex: Unknown