MAUDE Adverse Event Report: BAUSCH + LOMB 2.2 MM PHACO ACCESSARY PACK; UNIT PHACOEMULSIFICATION

Model Number	DP5531
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This investigation is ongoing.
Event or Problem Description
The user facility in new zealand reported during ia, the surgeon noticed a piece of green plastic floating in the eye and successfully removed the particle.Upon inspection, it was a piece of the green irrigation sleeve from the dp5531 accessory pack.Inspecting the sleeve, the origin was not obvious.However, when they proceeded to set up for the next procedure, the next irrigation sleeve was found to have an incomplete irrigation hole.The other sleeves in the pack were each individually inspected before each procedure, but no fault was found.The piece from the eye was not kept.The patient does not appear to have been harmed.No additional anesthesia was used.
Additional Manufacturer Narrative
Although the product was not received for evaluation, a review of photos provided showed a sleeve and needle inside of the patient''s eye which was unclear.It cannot be determined if a piece of the sleeve was missing or if there was a particle in the eye.The second and third photos showed the tip of the second sleeve.It is also unclear.However, it does appear to have two round irrigation port holes on the sides of the tip, as it should.The photos are not clear enough to determine if there was an incomplete punch.A review of the photos alone cannot confirm the particulate or the incomplete punch.The photos were sent to the vendor for evaluation.The vendor investigation concluded the frequency of changing cut punches is a likely contributor to the reported complaint and is revising their procedure to include routine inspection of the punches to ensure they are changed out when needed.
Additional Manufacturer Narrative
Correction: d4 corrected udi number.

• Brand Name: 2.2 MM PHACO ACCESSARY PACK
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 17773517
• Report Number: 0001920664-2023-70089
• Device Sequence Number: 20705707
• Product Code: HQC
• UDI-Device Identifier: 10757770057273
• UDI-Public: (01)10757770057273(17)271107(10)X3141
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K961831
• 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): 08/24/2023

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: DP5531
• Device Lot Number: X3141
• Was Device Available for Evaluation?: No
• 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; 10/11/2024
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/23/2023; 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• 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: STELLARIS UNIT.
• Patient Sex: Unknown