MAUDE Adverse Event Report: BAUSCH + LOMB 1.8 MM STABLECHAMBER PHACO PACK WITH MICS NEEDLE; UNIT, PHACOFRAGMENTATION

Model Number	BL5115-2
Medical Device Problem Code	Inability to Irrigate (1337)
Health Effect - Clinical Code	Intraocular Pressure Decreased (4468)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing and sterilization records were reviewed and found to be acceptable.There is an ongoing investigation with manufacturer of the tubing associated with this disposable pack (tubing part #107004337 - lots 3006797, 3007070, 3007071).Investigation is ongoing.Related reports: 0001920664-2023-70097, 0001920664-2023-70098.
Event or Problem Description
A user facility in france reported that the chamber collapsed during irrigation and aspiration.The irrigation stopped working after entering the eye.The procedure was delayed and ultimately completed two days later.The patient outcome is fine.
Additional Manufacturer Narrative
Correction to h6 investigation conclusion from 4315 to 11.The sample is being sent to the vendor for evaluation.This investigation is on going.Related reports: 0001920664-2023-70097, 0001920664-2023-70098.
Additional Manufacturer Narrative
The device was returned for evaluation.Visual inspection found the iv spike, drip chamber and a small section of the tubing has been cut off and was not returned.The tubing is dirty with fluid in the lines.A full functional test could not be performed due to the cut tubing.A partial test was performed using a stellaris elite system.The remaining fluid did flow through the tubing and out into the collection cassette indicating the returned piece of tubing and the cassette are not blocked.In addition, the air infusion line was tested and confirmed that the returned section of the air infusion line is not blocked.Manufacturing and sterilization records were reviewed and found to be acceptable.The iv spike, drip chamber and the missing piece of tubing could not be tested for blockages as they were not returned.There is an ongoing investigation with the manufacturer of the tubing associated with this disposable pack (tubing part #107004337 - lots 3006797, 3007070, 3007071).The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be determined.No corrective action required.Related reports: 0001920664-2023-70097, 0001920664-2023-70098.
Additional Manufacturer Narrative
The vendor''s visual exam of the returned product found no defects.In-line leak testing was performed and the tubeset passed.The root cause cannot 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.Related reports: 0001920664-2023-70097, 0001920664-2023-70098.

• Brand Name: 1.8 MM STABLECHAMBER PHACO PACK WITH MICS NEEDLE
• 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: 17930694
• Report Number: 0001920664-2023-70099
• Device Sequence Number: 12380118
• Product Code: HQC
• UDI-Device Identifier: 00757770058853
• UDI-Public: (01)00757770058853(17)241024(10)X4272
• Combination Product (Y/N): Y
• 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,Followup

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: 10/24/2024
• Device Model Number: BL5115-2
• Device Lot Number: X4272
• 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; Not provided
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 12/08/2023; 12/19/2023; 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• 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: STELLARIS SYSTEM AND ACCESSORIES; STELLARIS UNIT
• Patient Sex: Unknown