MAUDE Adverse Event Report: BAUSCH + LOMB NEEDLES MICROFLOW 2.2 30 DEGREE; UNIT, PHACOFRAGMENTATION

Model Number	DP8730S
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility in new zealand reported while being in attendance during a cataract procedure, the customer used stellaris elite along with bl5115-4 pack and dp8730s phaco needle.During the viscoelastic removal, and post iol implantation (j&j di-boo), a piece of metal fragment was found in the eye.There was no medical intervention required, no impact or injury to the patient, and no extra anesthesia required.The fragment was removed by the surgeon, with an increased surgical time of 2 minutes.
Additional Manufacturer Narrative
The product has been returned, but not evaluated yet.Manufacturing and sterilization records were reviewed and found to be acceptable.This investigation is ongoing.
Additional Manufacturer Narrative
Correction: d9 (date returned to manufacturer): 04nov2023.One small plastic specimen cup was returned in a plastic zip lock bag.The original packaging was not received.The part numbers and lot numbers cannot be verified or determined.The specimen cup contains an old style needle wrench, a blue/teal colored needle tip and a swab with a particle stuck to it.Microscopic examination was performed.The particle does have a metallic appearance and is approximately 311 microns long by 106 microns wide.The sliver-like particle is curled on the end.There is marring, gouges, scratches and material missing on the hub and the flats of the needle.Inspection of the needle wrench found the corners of flats on the needle wrench are marred, rounded and damaged.The particle will be sent to the lab for analysis.This investigation is ongoing.
Additional Manufacturer Narrative
The particle was sent to the lab for further analysis.The sample was analyzed using energy-dispersive spectrometer (eds) equipped with a scanning electron microscope (sem).Eds analysis indicated the sample consists of iron, carbon, chromium, nickel, manganese, and silicon.This is consistent with stainless steel.The old style needle wrench does have a stainless steel component.The returned needle wrench had extensive damage.The instructions for use (ifu) contains instructions on the proper use of the needle wrench.It is not possible to definitively determine the source of the returned particle due lack of traceability information provided, damaged condition of the returned wrench and limitations of the analytical method.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: NEEDLES MICROFLOW 2.2 30 DEGREE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 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: 17975156
• Report Number: 0001920664-2023-70109
• Device Sequence Number: 3518488
• Product Code: HQC
• UDI-Device Identifier: 00757770057252
• UDI-Public: (01)00757770057252(17)271014(10)X2986
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Followup
• Report Date (Section B): 09/26/2023

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: DP8730S
• Device Lot Number: X2986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• 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; Not provided
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/29/2023; 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BL5115-4 PACK.; BL5115-4 PACK.
• Patient Sex: Unknown