MAUDE Adverse Event Report: PHACO ACCESSORY PACK; UNIT, PHACOFRAGMENTATION

Model Number DP5531

Device Problem Particulates (1451)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturing, sterilization and lot history records were reviewed and found to be acceptable.The investigation is ongoing.

Event Description

A user facility in (b)(6) reported that, during surgery, the surgeon found a foreign body in the patient's eye.The surgeon saw the foreign body before she put the phaco tip inside the patient's eye, as she was adjusting the positioning of the sleeve and tip.The surgeon managed to retrieve the foreign body from the patient's eye.The surgery was not prolonged and no additional anesthesia was required.The patient is ok and has recovered.

Manufacturer Narrative

The particle was returned for evaluation.Visual inspection found the particle was approximately 1141 x 565microns in size, white colored and hard to the touch.Analysis of the particle was performed using an energy-dispersive spectrometer (eds) equipped scanning electron microscope (sem).Eds analysis indicated the particle consisted of primarily carbon and oxygen.Lesser concentrations of chlorine, potassium, sodium, phosphorus, sulfur, calcium, and magnesium were also detected.This is consistent with organic material, saline residue and mineral deposits.Further analysis was performed using a fourier transform infrared (ftir) spectrometer.The ftir analysis of the particle produced a spectrum consistent with that of protein.Protein is not utilized in the manufacture of the product and therefore the source of the particle can not be determined.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.The investigation is complete.

• Brand Name: PHACO ACCESSORY PACK
• Type of Device: UNIT, PHACOFRAGMENTATION
• MDR Report Key: 11690668
• MDR Text Key: 248544230
• Report Number: 0001920664-2021-00045
• Device Sequence Number: 1
• Product Code: HQE
• Combination Product (y/n): Y
• PMA/PMN Number: K961831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• 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: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DP8730S LOT: W7006