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	01/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in the united kingdom reported that some hard plastic came out of one of cartridge sets.The surgeon retrieved the plastic out of the patient''s eye without causing any damage or impact to the patient.The procedure was prolonged for about 1-2 minutes and the surgery was completed without additional anesthesia usage.The product number is still unknown and is pending return.
Additional Manufacturer Narrative
The device has been requested for evaluation.The investigation is ongoing.
Additional Manufacturer Narrative
The lot number is unknown, therefore the device history record could not be reviewed.Since the product has not been returned for evaluation, further investigation into a root cause is not possible.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
None of the pack components were returned for evaluation.One small plastic vial with an orange lid was returned in a plastic bag that was wrapped in bubble wrap.The vial is filled with an unknown fluid.There is a semi-clear or translucent particle floating in the vial.The particle is hard to the touch.It is approximately 846 microns wide by 877 microns long.The source and origin of the particle cannot be determined, as there is no traceability to any product id or lot number.
Additional Manufacturer Narrative
D1.Brand name from: unknown disposable pack to stellaris phaco premium pack with mics needle.D4.Model no.From: unknown to bl5114.D4.Udi from unknown to (b)(4).H10: from: the source and origin of the particle cannot be determined, as there is no traceability to any product id or lot number to the source and origin of the particle cannot be determined, as there is no traceability to any lot number.

• Brand Name: STELLARIS PHACO PREMIUM PACK WITH MICS NEEDLE.
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 3365 treecourt industrial blvd; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd.; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 16311776
• Report Number: 0001920664-2023-00010
• Device Sequence Number: 20352334
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/09/2023

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?: No
• 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: 02/07/2023
• Supplement Report FDA Received Date: 03/24/2023; 05/18/2023; 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS SYSTEM AND ACCESSORIES
• Patient Sex: Unknown