MAUDE Adverse Event Report: BAUSCH + LOMB ADAPTIVE FLUIDICS STD PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL5115-2
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned.Manufacturing and sterilization records for this device were reviewed and found to be acceptable.The investigation is ongoing.See related report: 0001920664-2023-70036.
Event or Problem Description
The user facility in france reported that during the procedure the irrigation was suddenly interrupted resulting in chamber movement and drooping of the eye.A capsular rupture occurred and an anterior vitrectomy was required.When the vitreotome was connected to the pipes, lack of infusion was noticed again.The cassette was changed and again no infusion occurred.A third cassette was used and the irrigation worked.The surgeon was able to proceed with resolving the capsular rupture and placement of the implant.This report is for the second cassette.
Additional Manufacturer Narrative
One opened bl5115-2 pack from lot x3374 was returned.Visual inspection found the assembly dirty with fluid in the lines.A functional test was performed using a stellaris elite.The collection cassette was captured and recognized by the system.The assembly passed the self-vacuum test and primed.In addition, the irrigation flow was tested 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 did start and stop when prompted by two of the three methods used.However, when initiating "continuous irrigation" on the touch screen, the fluid does not flow from the iv bottle down and out the end of the irrigation tubing.Further testing found that air does not flow or has a diminished air flow through the blue-striped airline.This sample has been sent to the vendor for evaluation.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.This investigation is ongoing.See related report: 0001920664-2023-70036.
Additional Manufacturer Narrative
Correction to d9 from: 01-may-2023 to: 01-aug-2023.H10 ¿the previous report included information not related to this incident.Therefore the last reported evaluation results do not apply¿ evaluation completed.Two opened packs were returned.Visual inspection found the assemblies dirty with fluid in the lines.Both assemblies were returned with the tubing iv spike inserted into balanced salt solution bottles.A functional test was performed using a stellaris elite.The collection cassettes were captured and recognized by the system.The assemblies passed the self-vacuum test, and primed.In addition, the irrigation flow was tested using two methods of control.The touch screen, the on/off switch, and the foot controller.The irrigation did start and stop when prompted by the foot controller.However, when initiating "continuous irrigation" on the touch screen, the fluid does not flow from the iv bottle down and out the end of the irrigation tubing.Further testing found that air does not flow or has a diminished air flow through the blue-striped airline.The supplier reported there is some air flow and there are other potential reasons that may affect irrigation, such as kinked tubing, blocked filter, detached manifold and detached tubing, so it cannot be definitively stated that the occlusion is the only source of the flow issue reported.The root cause for the flow issue can not be determined because there are too many potential causes for reduced flow.No corrective action is required.

• Brand Name: ADAPTIVE FLUIDICS STD PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd; saint louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 16771280
• Report Number: 0001920664-2023-70037
• Device Sequence Number: 11576398
• Product Code: HQC
• UDI-Device Identifier: 00757770058853
• UDI-Public: (01)00757770058853(17)240617
• 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,Followup
• Report Date (Section B): 03/29/2023

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 Expiration Date: 06/17/2024
• Device Model Number: BL5115-2
• Device Lot Number: X3374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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; Not provided
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 06/12/2023; 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• 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: BALANCED SALT SOLUTION.; STELLARIS UNIT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown