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

Model Number DP5531

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2023

Event Type  malfunction  

Manufacturer Narrative

This investigation is ongoing.

Event 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.

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.

• Brand Name: 2.2 MM PHACO ACCESSARY PACK
• Type of Device: 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
• MDR Text Key: 323726940
• Report Number: 0001920664-2023-70089
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K961831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: DP5531
• Device Lot Number: X3141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STELLARIS UNIT.