MAUDE Adverse Event Report: BAUSCH + LOMB 2.4 MM PHACO ACCESSORY PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL3124S
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sleeve was discarded by the facility; therefore, an evaluation cannot be performed.Manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is ongoing.Report 2 of 2, see related medwatch report number: 0001920664-2024-00138.
Event or Problem Description
The user facility in switzerland reported that during the procedure, a round section of the side port on the sleeve got into the patient's eye, although the sleeve had been rinsed out beforehand.The section of the sleeve was removed immediately from the eye using the suction system.The procedure was extended by approximately five minutes.
Additional Manufacturer Narrative
The product was not available for evaluation.However, the complaint description is consistent with an incomplete punch of the irrigation port on the sleeve.The supplier has confirmed the lot involvement and has taken corrective action to address this issue.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.Report 2 of 2, see related medwatch report number: 0001920664-2024-00138.

• Brand Name: 2.4 MM PHACO ACCESSORY PACK
• 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 ; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 20613142
• Report Number: 0001920664-2024-00139
• Device Sequence Number: 20716597
• Product Code: HQC
• UDI-Device Identifier: 00757770059614
• UDI-Public: (01)00757770059614(17)290421(10)X6195
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 10/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BL3124S
• Device Lot Number: X6195
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2024
• 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
• Patient Sex: Unknown