MAUDE Adverse Event Report: BAUSCH + LOMB, INC STELLARIS ULTRASOUND HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number	BL3170
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	12/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record (dhr) found that serial # ush29859 met all physical and functional requirements.The investigation is ongoing.
Event or Problem Description
The user facility in the united kingdom reported that a white material was observed in the phaco tip during surgery.The handpiece was removed from the eye and flushed.Surgery continued and later on a corneal burn was observed.The wound was sutured at the end of the case.Surgery was increased by 0-15 minutes.Additional information has been requested.
Additional Manufacturer Narrative
Correction: d4.Serial number (b)(6).The device history record review found that the handpiece met all physical and functional requirements at the time of manufacture.Although product has been requested, it has not been returned to date.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 was required.This investigation will be reopened if the product is received.The investigation is complete.
Additional Manufacturer Narrative
The device was received and the evaluation completed.One stellaris handpiece was returned.Visual inspection found the nose cone and transducer horn dented and marred.The cable is deformed at the lemo connector strain relief.A functional test was performed using a stellaris system.The handpiece tuned, primed, and functioned as intended.Additionally, the handpiece was run at 100% power for one full minute without irrigation or aspiration hook-up.The handpiece did not get hot during testing.We are unable to determine the root cause.No further action is required.We will continue to monitor complaints of this nature.The investigation is complete.

• Brand Name: STELLARIS ULTRASOUND HANDPIECE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC; 1400 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 blv; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 16199633
• Report Number: 0001920664-2023-00005
• Device Sequence Number: 6066922
• Product Code: HQC
• UDI-Device Identifier: 00757770480852
• UDI-Public: (01)00757770480852
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2022

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
• Operator of Device: Health Professional
• Device Model Number: BL3170
• Device Catalogue Number: BL3170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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; Not provided
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 03/03/2023; 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS SYSTEM AND ACCESSORIES
• Patient Sex: Unknown