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

Model Number	BL5114
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Endophthalmitis (1835)
Date of Event	08/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility in the united kingdom reported a patient developed an infection in their eye and diagnosed with endophthalmitis.Medical intervention: post operation medication.
Additional Manufacturer Narrative
The product is not available for return.This investigation is ongoing.
Additional Manufacturer Narrative
B5 and b7 - additional information.Product is not available for return and the lot number is unknown.Based upon the information provided it is not possible to investigate further for root cause.A letter certifying the sterility and quality of all bl5114 product was provided for the complainant investigation.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.
Event or Problem Description
Patients symptoms were pain, redness and hazy cornea.The patient was seen at (b)(6) on a monday and then referred to leichester royal infirmary (lri) on the same day.The patient was discharged from lri but still requires follow up appointments.Leicester royal infirmary handled the patient medication treatment.Result of lab culture ¿ endophthalmitis (pseudomonas).

• 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: 17838422
• Report Number: 0001920664-2023-70096
• Device Sequence Number: 17998639
• Product Code: HQC
• UDI-Device Identifier: 00757770057542
• UDI-Public: 00757770057542
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model 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: 09/28/2023
• Supplement Report FDA Received Date: 10/19/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT AND BSS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown