MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS PHACO PREMIUM PACK WITH MICS NEEDLE.; UNIT PHACOEMULSIFICATION

Model Number	BL5114
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Codes	Inflammation (1932); Eye Pain (4467); Eye Irritation (4803)
Date of Event	09/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in france reported that several months post surgery, patient had symptoms of abnormal pain and burning.It was reported it seemed like a metal residue was observed in the iris and there was posterior chamber inflammation.The patient was treated with local and regional corticotherapy.Surgery is planned to remove the particle however, it has not been scheduled.
Additional Manufacturer Narrative
The lot number is not available and product was discarded.Therefore a review of the device history record cannot be performed.
Additional Manufacturer Narrative
The product was not available for return.The information provided was insufficient to investigate further for a root cause.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 PHACO PREMIUM PACK WITH MICS NEEDLE.
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 16831170
• Report Number: 0001920664-2023-70039
• Device Sequence Number: 1929655
• Product Code: HQC
• UDI-Device Identifier: 00757770057542
• UDI-Public: (01)00757770057542
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/05/2023

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: BL5114
• Device Catalogue Number: BL5114
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 79 YR
• Patient Sex: Unknown