MAUDE Adverse Event Report: BAUSCH + LOMB PREMIUM VACUUM PHACO; UNIT, PHACOFRAGMENTATION

Model Number	BL5110
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Corneal Edema (1791)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been requested.A review of the video provided was performed.The video showed an anterior pack assembly in the surgical field.The irrigation tubing was inserted into a glass balanced salt solution bottle and there was fluid seen flowing in the tubing.The cassette is shown while in use, as a person placed a white paper towel alongside the irrigation manifold base on the tubing manifold base.The paper towel absorbed the fluid that could be seen coming from around the irrigation manifold base.The assembly was leaking.The assembly cannot function properly in this condition.The cause of the leak cannot be determined by viewing the video alone.Manufacturing and sterilization records were reviewed and found to be acceptable.Investigation is ongoing.
Event or Problem Description
It was reported by a user facility in turkey that during the case, water leaked from the cassette chamber of the device.The case was paused until the pump was dried and a new cassette was installed.Due to the drying time of the cassette chamber the case was prolonged by approximately one hour.Sedation was given to the patient.In addition, while the patient was under the effect of local anesthesia, they moved causing an edema in the cornea.The patient is now in good condition.
Additional Manufacturer Narrative
Visual inspection found one opened bl5110 pack assembly, the pack tray and label are not physically damaged.Dried solution was visible on top of the tubing manifold base around the irrigation manifold.A functional test was performed with a syringe filled with water.The water was injected into the iv spike and flowed through the tubing and down to the collection cassette where the water was seen leaking around the irrigation manifold base on the tubing manifold base assembly.The vendor was notified of this complaint and the returned product.The vendor's review of the video confirmed the cassette leaked around the irrigation manifold.The vendor type of damage is typically caused by removing the cassette from the weld nest in the wrong fashion.It can not be determined if the user or manufacturing caused the damage.Root cause can not be determined.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: PREMIUM VACUUM PHACO
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 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: 19709103
• Report Number: 0001920664-2024-00085
• Device Sequence Number: 11542103
• Product Code: HQC
• UDI-Device Identifier: 10757770057013
• UDI-Public: (01)10757770057013(17)260221(10)X3831
• Combination Product (Y/N): N
• PMA/510(K) Number: K063331
• 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): 06/24/2024

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: 02/21/2026
• Device Model Number: BL5110
• Device Lot Number: X3831
• 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: 06/24/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown