MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS BASIC VACUUM PHACO PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL5111
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two possible lot numbers were reported, however it is unknown which lot pertains to the reported event.The product is not available for return, however the foreign material is in the process of returning to the evaluation center.A review of the device history record of the first possible lot did not identify any anomalies or nonconformities that could be related to this event.The investigation of this event is in progress.
Event or Problem Description
A user facility in the united kingdom reported that an unknown specimen was found in the anterior chamber during phacoemulsification.The specimen was removed by aspiration and appears to be plastic.There was no reported patient impact.
Additional Manufacturer Narrative
The lot number reported is the lot number in question.One test tube vial with a red lid was returned in a plastic bag.The original packaging was not returned.The part number and lot number cannot be verified or determined.Visual inspection found what looks like a brown hair or fiber-like particle inside the test tube vial.The particulate has been sent to the vendor for additional evaluation.This investigation is on going.
Additional Manufacturer Narrative
The vendor reviewed the device history records for all components and no anomalies were found.The production area was reviewed and there was no foreign matter observed on the product floor or in current inventory.The vendor cannot determine what the foreign matter is and where it derived from.The root cause can not be determined.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.Correction to d4: udi from (b)(4) to (b)(4).

• Brand Name: STELLARIS BASIC VACUUM PHACO PACK
• 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 ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 18675195
• Report Number: 0001920664-2024-70014
• Device Sequence Number: 12611407
• Product Code: HQC
• UDI-Device Identifier: 00757770057092
• UDI-Public: (01)00757770057092(17)260923(10)X5142
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2024

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 Expiration Date: 09/23/2026
• Device Model Number: BL5111
• Device Lot Number: X5142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 05/09/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 03/21/2024; 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT AND ACCESSORIES
• Patient Sex: Unknown