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

Model Number BL5114

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Endophthalmitis (1835)

Event Date 08/19/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

The product is not available for return.This investigation is ongoing.

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 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.
• 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: 17838422
• MDR Text Key: 324524512
• Report Number: 0001920664-2023-70096
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00757770057542
• UDI-Public: 00757770057542
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 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
• Device Operator: Health Professional
• Device Model 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: 09/28/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/19/2023
• 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
• Treatment: STELLARIS UNIT AND BSS.
• Patient Outcome(s): Required Intervention