MAUDE Adverse Event Report: BAUSCH + LOMB 25G BI-B COMBINED ELITE W WF; UNIT, PHACOFRAGMENTATION

Model Number	SE5525WVB
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in the netherlands reported that debris entered the patient's eye during surgery.The debris was removed with forceps and there was no impact to the patient.
Additional Manufacturer Narrative
The lot number is unknown therefore a device history record review cannot be performed.The investigation is ongoing.
Additional Manufacturer Narrative
Correction: d4 lot# x2619.A review of photos provided by the user facility was performed.One iv spike piercing pin is visible in the photo.The rest of the pack components are not shown in the photo.One particle can be seen at the port on the tip of the piercing pin shaft.In addition, there are photos of a particle lying in a blue tray.It cannot be determined if this is the same particle from the piercing pin tip or if it is a second particle.The particles appear to be light grey in color or possibly white.The size, texture, and material makeup of the particle(s) are unknown.It should be noted that the balanced salt solution bottle and the stopper were not shown in the photos.Although the balanced salt solution stoppers are often a light grey color, the source and origin of the particle(s) cannot be determined by viewing the photos alone.The device has been received.Evaluation is anticipated but not yet begun.A review of the device history record found no nonconformities or anomalies related to this complaint.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.The investigation is ongoing.
Additional Manufacturer Narrative
One piercing spike was returned in a plastic bag.Microscopic examination was performed and found a cream colored, rubber-like particle sticking out of the hole inside the tip of the piercing pin which appeared to have flashing or burrs on the side port.The particle was removed for inspection.The material is soft, elastic, and stretchy.The balanced salt solution was not returned and could not be inspected.The particle has been sent to the lab for analysis.This investigation is on going.
Additional Manufacturer Narrative
Correction to d4 udi (b)(4).The sample was analyzed using an energy-dispersive spectrometer (eds) equipped with a scanning electron microscope (sem).Eds analysis indicated that the sample consists primarily of organic content.The sample was analyzed using a fourier transform infrared (ftir) spectrometer.The ftir produced a spectrum not consistent with anything in their library.The sample was also analyzed using pyrolysis/gas chromatography.Gc/ms was unable to detect anything in their current library.The results concluded that the particle does not match the appearance of any material used in their process.Based upon the investigation it is not possible to determine the root cause or source of the particles reported by the customer.We will continue to monitor for the reported complaints.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.
Additional Manufacturer Narrative
The piercing spike was evaluated by the supplier.A "stringy" white material was found in the thru hole of the spike and reviewed under a microscope.The material did not appear to be material common to the pre-piercing spike assembly and does not have the same color or texture of the resin used to mold the spike.It cannot be determined how or where the material was introduced.It was not observed on their production floor or in the assembly of the part.

• Brand Name: 25G BI-B COMBINED ELITE W WF
• 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: 16088968
• Report Number: 0001920664-2022-00176
• Device Sequence Number: 2147567
• Product Code: HQC
• UDI-Device Identifier: 00757770059768
• UDI-Public: (01)00757770059768(17)240219(21)X2619
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K170052
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/12/2022

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: SE5525WVB
• Device Catalogue Number: SE5525WVB
• Device Lot Number: X2619
• 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; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/15/2023; 03/28/2023; 05/09/2023; 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• 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