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

Model Number BL5114

Device Problem Particulates (1451)

Patient Problems Inflammation (1932); Eye Pain (4467)

Event Date 09/23/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The lot number is not available and product was discarded.Therefore a review of the device history record cannot be performed.

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.
• Type of Device: 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
• MDR Text Key: 314164307
• Report Number: 0001920664-2023-70039
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00757770057542
• UDI-Public: (01)00757770057542
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR