MAUDE Adverse Event Report: BAUSCH + LOMB, INC. UNKNOWN STELLARIS PACK; UNIT, PHACOFRAGMENTATION

Model Number UNKNOWN STELLARIS PACK

Device Problem No Flow (2991)

Patient Problem Eye Injury (1845)

Event Date 03/19/2024

Event Type  Injury  

Manufacturer Narrative

The device has been requested and has yet to be returned.The lot number is not known.The dhr review cannot be performed at this time.However, the dhr review will be updated once the lot number information becomes available.The investigation is underway.

Event Description

The user facility reports that the anterior chamber collapsed during segment removal due to a lack of balanced salt solution.The cornea collapsed on the phaco needle and damaged the central entopallia.The patient will need a cornea transplant.

• Brand Name: UNKNOWN STELLARIS PACK
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC.; 4100 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 19140168
• MDR Text Key: 340559837
• Report Number: 0001920664-2024-00060
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN STELLARIS PACK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• 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 ELITE SYSTEM,ACCESSORIES,BSS