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

Model Number	BL5114
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A lot number was not provided; therefore, the sterilization and lot history records could not be reviewed.The lot number has been requested.The investigation is ongoing.
Event or Problem Description
It was reported by the user facility in the united kingdom that a piece of debris come out of the phaco probe inside the eye.The particle was removed using the aspiration on the phaco probe.No injury or impact to the patient was reported.
Additional Manufacturer Narrative
A needle wrench, purple needle tip, light blue irrigation sleeve, and the particle was returned for evaluation.The original packaging was not received, therefore the part number and lot numbers cannot be verified or determined.Microscopic examination of the components found that they are all dirty with particulates and dried solution visible.The needle hub, shaft and tip area are marred, scratched and missing material.The hubs have some rounding of the flats at the corners.The ribs of the needle wrench are damaged and the metal end has rounded corners.The irrigation sleeve looks used and has many particles all over and inside of it.The returned white particle is approximately 781 microns long by 566 microns wide.The particle is hard to the touch.The source and origin of the particle cannot be determined.The particle will be sent to the lab for analysis.This investigation is ongoing.
Additional Manufacturer Narrative
Correction d4 (udi) from: (b)(4) to: (b)(4).The lab reported that the returned particle of unknown origin, consists primarily of organic content.Neither the fourier transformed infrared or gas chromatography-mass spectroscopy spectrums indicated a composition consistent with anything in their libraries.The source of the returned particle could not be determined.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.
Additional Manufacturer Narrative
Correction h6 investigation findings: from 213 to 202.

• Brand Name: STELLARIS PHACO PREMIUM PACK WITH MICS NEEDLE
• Common Device Name: 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 ; 6362263220
• MDR Report Key: 16234777
• Report Number: 0001920664-2023-00004
• Device Sequence Number: 6852098
• Product Code: HQC
• UDI-Device Identifier: 00757770057542
• UDI-Public: (01)00757770057542
• 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
• Report Source: Foreign,Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BL5114
• Device Catalogue Number: BL5114
• Device Lot Number: UNKNOWN
• 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; Not provided
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 03/20/2023; 04/17/2023; 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown