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	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not available for return as it was discarded.The complaint description is consistent with the presence of an irrigation hole punch from the yellow irrigation sleeve associated with this device.The sterilization and lot history records were reviewed and found to be acceptable.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.The disc-like particle is consistent with an incomplete sleeve punch.The supplier has taken corrective action to address this issue.The investigation is complete.
Event or Problem Description
The user reported that a disc from the yellow silicone phaco sleeve which is normal punched out from the tip was not fully removed from the sleeve and during the case the yellow silicone disc appeared in the anterior chamber.Which required the surgeon to remove with urata forceps.Scrub threw away after case.No patient injury occurred.

• Brand Name: ADAPTIVE FLUIDICS STANDARD 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: amy frutiger ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 23815624
• Report Number: 0001920664-2025-00126
• Device Sequence Number: 13286485
• Product Code: HQC
• UDI-Device Identifier: 00757770058853
• UDI-Public: (01)00757770058853(17)280712
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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
• Device Model Number: BL5115-2
• Device Lot Number: X8462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2025
• 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