MAUDE Adverse Event Report: BAUSCH + LOMB PHACO NEEDLE PACK; UNIT, PHACOFRAGMENTATION

Model Number	DP8430S
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was requested but has not yet been returned.The lot number is unknown.Therefore, the device history records cannot be reviewed at this time.The investigation is ongoing.
Event or Problem Description
A user facility in the united kingdom reported a white particle in the patient's eye during cataract removal.The needle wrench that was used was examined and noticed signs of tip wrench.The staff was reminded of the correct way to utilize a wrench.There was no medical intervention required, no impact or injury to the patient, and no extra anesthesia required.The particle was quickly removed using forceps and procedure continued without issue.
Additional Manufacturer Narrative
Evaluation completed.One needle wrench and one white particle were returned inside of a small plastic specimen cup.The rest of the pack components and the label were not returned.The part number and lot number cannot be verified or determined.The particle was hard to the touch.Microscopic examination of the white colored particle was performed and found that it was approximately 1102 microns wide by 1527 microns long.Visual inspection found the flats of the needle wrench was marred and damaged.Material was missing from the damaged locations on the needle wrench.This type of damage is similar in appearance to damage seen when over tightening the needle tip with the non-metal end of the wrench.It should be noted that over-torquing could contribute to the generation of particulates from the plastic needle wrench.The returned particle was similar in appearance and color as the damaged material on the flats of the needle wrench.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 device has been returned, but not evaluated yet.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.This investigation is ongoing.

• Brand Name: PHACO NEEDLE PACK
• 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 ct. industrial blvd.; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 17194934
• Report Number: 0001920664-2023-70063
• Device Sequence Number: 5806755
• Product Code: HQE
• UDI-Device Identifier: 00757770057726
• UDI-Public: (01)00757770057726
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/31/2023

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: DP8430S
• Device Lot Number: UNKNOWN
• 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: 06/23/2023
• Supplement Report FDA Received Date: 08/03/2023; 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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