MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ELITE 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	01/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned and the lot number is unknown.Therefore a review of the device history record cannot be performed.The trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.The investigation is ongoing.
Event or Problem Description
The user facility in switzerland reported that a small piece of plastic ejected from the sleeves and entered the eye during phacoemulsification.It looks like it is the rest from the side ports (cut but was still in the sleeve).Forceps were used to extract the piece from the eye.
Additional Manufacturer Narrative
The device was discarded and the lot number is unknown.Therefore a review of the device history record cannot be performed.The trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.
Event or Problem Description
Additional information received since the initial report.It was reported that the sleeves have holes and the plastic piece that was cut remained on the sleeve until surgery.

• Brand Name: STELLARIS ELITE ADAPTIVE FLUIDICS STANDARD PACK
• 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: 18790352
• Report Number: 0001920664-2024-70030
• Device Sequence Number: 15392857
• Product Code: HQC
• UDI-Device Identifier: 00757770058853
• UDI-Public: (01)00757770058853
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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: BL5115-2
• Device Lot Number: UNKNOWN
• 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: 02/27/2024
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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