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

Model Number	BL5115-2
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility in germany reported that a particle of the sleeve entered the patient''s eye during the procedure.The particle was removed from the eye.No patient impact was reported.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the device history record did not identify any anomalies or nonconformities that could be related to this event.The investigation of this event is in progress.The initial report was submitted on 03/15/2024 under incorrect cfn/fei/hcfa id ((b)(4))-core id (b)(4).Resubmitting initial report under correct cfn/fei/hcfa id ((b)(4)).
Additional Manufacturer Narrative
Corrected d4 udi#: (b)(4).The device is not available for evaluation as it was discarded.A review of the device history record found no nonconformities or anomalies related to this event.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 all available information, the root cause could not be determined.

• Brand Name: ADAPTIVE FLUIDICS STANDARD PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB; 3365 tree ct. industrial blvd.; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 19128050
• Report Number: 0001920664-2024-00056
• Device Sequence Number: 18213691
• Product Code: HQC
• UDI-Device Identifier: 00757770058853
• UDI-Public: (01)00757770058853(17)250128(10)X4847
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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 Expiration Date: 01/28/2025
• Device Model Number: BL5115-2
• Device Lot Number: X4847
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2023
• 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
• Patient Sex: Unknown