MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ELITE ADAPTIVE FLUIDICS BASIC PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL5115-2
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.Manufacturing and sterilization record were reviewed and found to be in acceptable.The investigation of this event is on going.
Event or Problem Description
The user facility in germany reported that a piece of the silicon-sleeve entered the patient''s eyes during the procedure.It was reported that it was badly punched-out.The piece was removed by the surgeon without any difficulties.
Additional Manufacturer Narrative
The product has been requested but not yet received.Scar 2024-02 was issued to the vendor's supplier.Vendor confirmed that product is related to scar 2024-02.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.The investigation is still ongoing.
Additional Manufacturer Narrative
One card board box was returned containing two bl5115-2 pack labels, one empty dp5531 pouch and two yellow irrigation sleeves.It cannot be determined which bl5115-2 pack the sleeves belong to.Visual inspection found both sleeves dirty with particulates all over.Microscopic examination was performed.The first irrigation sleeve has what looks like a divot or scoop of material missing just before the entrance into the shaft from the hub.The missing piece of material is similar in size, shape and color to the sleeve and was found stuck to the inside wall of the shaft.The second irrigation sleeve was found to have what looks like a piece of the shaft or a remnant of a hole punch that is stuck to the inside wall of the shaft.The sleeves were sent to the vendor for investigation.Manufacturing and sterilization records were reviewed and found to be acceptable.At this time, no remedial, corrective, preventive or field safety corrective action is required.The investigation of this event is on going.
Additional Manufacturer Narrative
The product was sent to the vendor for evaluation.The evaluation results: the sleeve was returned with the irrigation holes at the correct location.A circular piece punched out form irrigation hole was seen inside the sleeve tube.The batch history review showed no abnormality was found.This is the first report for lot number 177706.This report is filed as a functional defect since the report of a circular silicon piece punched out form the irrigation hole was left in the sleeve was confirmed.This investigation is complete.

• Brand Name: STELLARIS ELITE ADAPTIVE FLUIDICS BASIC PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 19313096
• Report Number: 0001920664-2024-00071
• Device Sequence Number: 19585552
• Product Code: HQC
• UDI-Device Identifier: 00757770058853
• UDI-Public: (01)00757770058853(17)250511
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/15/2024

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: 05/11/2025
• Device Model Number: BL5115-2
• Device Lot Number: X5413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/05/2024; 08/01/2024; 09/09/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 07/02/2024; 08/23/2024; 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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