MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ELITE ADAPTIVE FLUIDICS STANDARD PACK; UNIT PHACOEMULSIFICATION

Model Number	BL5115-2
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in germany reported that the infusion hole of the sleeve was incompletely perforated.Due to the infusion-pressure the partially perforated sleeve material was rinsed into the eye.The surgeon removed the sleeve-particle with viscoelastic and a forceps from the eye.There was no patient impact, no significant prolongation of procedure and no additional medication required.
Additional Manufacturer Narrative
The product has not been returned.The investigation is ongoing.
Additional Manufacturer Narrative
Correction: d4 - lot number, expiration date, and udi number.H4 - manufacture date.
Additional Manufacturer Narrative
Though the product samples was not available for return the complaint description is consistent with the presence of an irrigation hole punch from the yellow irrigation sleeve associated with this device.Scar 2024-02 was opened by the supplier to address the reported issue on 03/18/2024.The most probable root cause was determined to be a component issue.A lot number was not provided; therefore, the sterilization and lot history records could not be reviewed.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.

• Brand Name: STELLARIS ELITE ADAPTIVE FLUIDICS STANDARD PACK
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 20990099
• Report Number: 0001920664-2024-00169
• Device Sequence Number: 15410218
• Product Code: HQC
• UDI-Device Identifier: 00757770058853
• UDI-Public: (01)00757770058853
• 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,Followup
• Report Date (Section B): 12/12/2024

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: 06/30/2025
• Device Model Number: BL5115-2
• Device Lot Number: UNKNOWN
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 01/29/2025; 03/04/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 02/18/2025; 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2024
• 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