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

Model Number	BL3170
Medical Device Problem Codes	Suction Problem (2170); Noise, Audible (3273)
Health Effect - Clinical Code	Eye Burn (2523)
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported during pre-phaco and sculpt the handpiece didn¿t feel like it was aspirating and made a unique noise, similar to the tip not being fully tightened.When checked, the tip was tight.This patient received one suture to close the wound and basic post-op medication.
Additional Manufacturer Narrative
The product was returned, but not evaluated yet.A thorough review of the manufacturing records associated with this product has been performed and we have not identified any issues or discrepancies with these records.This investigation is ongoing.
Additional Manufacturer Narrative
The evaluation has been completed.One bl3170 stellaris handpiece, serial number ush69735 was returned.Visual inspection found the nose cone dented.The cable was deformed at approximately 1/2 way and was also deformed at the lemo connector strain relief, and the wires were twisted inside the cable jacket.A functional test was performed using a stellaris system.The handpiece did not tune and would not function.Error codes usm15 ¿ ¿unable to read ultrasound handpiece data.Attempt to tune the handpiece to confirm proper operation¿ and usm08 - "the ultrasound handpiece has failed the tuning process" appeared on the monitor.The cause of the damage cannot be determined.The handpiece could not be tested as it did not tune.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.

• Brand Name: STELLARIS ULTRASOUND HANDPIECE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 treecourt industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 18047899
• Report Number: 0001920664-2023-70115
• Device Sequence Number: 18149227
• Product Code: HQC
• UDI-Device Identifier: 00757770480852
• UDI-Public: (01)00757770480852(11)190430
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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): 09/22/2023

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: BL3170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• 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: 11/01/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown