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)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the user facility in the united kingdom that the phaco needle sheath had a particle come out from it.The particle was noticed once it left the tip of the phaco sleeve and came out in the irrigation flow and did enter the patient's eye.No injury or impact to the patient was reported.
Additional Manufacturer Narrative
The product has been collected and shipment is anticipated.Manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
Correction to d4 unique identifier (udi#): (b)(4).Correction to h4 date of manufacture: 12-dec-2022 to: 21-dec-2022.Correction to h6 component code: 3067 to 4755.Returned was one opened pack tray with no label and a brown bottle labeled lot x3186 containing one light blue irrigation sleeve.Visual examination of the sleeve showed it was dirty with particulates and dried solutions all over.Though many tiny particles are visible on the sleeve, no specific particle could be identified as described in the complaint.The rest of the pack components including the needle wrench were not received.Due to evidence of use, the source and origin of the particles cannot 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.
Event or Problem Description
The particle was removed with irrigation aspiration.
Additional Manufacturer Narrative
Correction h6 investigation findings: from: 3221 to: 202.

• Brand Name: STELLARIS BASIC VACUUM PHACO PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; 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: 16529965
• Report Number: 0001920664-2023-00019
• Device Sequence Number: 16805752
• Product Code: HQC
• UDI-Device Identifier: 10757770057099
• UDI-Public: (01)10757770057099(17)251112(10)X3186
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2023

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 Expiration Date: 11/12/2025
• Device Model Number: BL5111
• Device Catalogue Number: BL5111
• Device Lot Number: X3186
• 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: 03/13/2023
• Supplement Report FDA Received Date: 04/24/2023; 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• 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