MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS BASIC VACUUM PHACO PACK; UNIT, PHACOFRAGMENTATION

Model Number BL5111

Device Problem Particulates (1451)

Patient Problem Capsular Bag Tear (2639)

Event Date 01/30/2024

Event Type  Injury  

Event Description

The user facility in the united kingdom reported that a foreign object, appearing as a white, hard material shaped like a donut with sharp edges, pinged into the eye from within the phaco tip during surgery.The surgeon believes it came from a solidified substance around the phaco tip under the sheath.The foreign object struck the superior-temporal posterior capsule, resulting in a tear during the procedure.A viscoelastic was used to prevent the vitreous from coming forward.The foreign body could not be removed from the eye and there was no vitreous left in the anterior chamber at the end.The patient was sent to a vitreoretinal surgeon to remove the foreign body and insert the intraocular lens.

Manufacturer Narrative

The product is not available for return.The investigation of this event is in progress.

Manufacturer Narrative

The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.The investigation is complete.

• Brand Name: STELLARIS BASIC VACUUM PHACO PACK
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd; saint louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 18998627
• MDR Text Key: 338879976
• Report Number: 0001920664-2024-00047
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 0757770057092
• UDI-Public: (01)0757770057092(17)260930(10)X5179
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: BL5111
• Device Lot Number: X5179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DP8230S, 85786ST