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

Model Number DP5531

Device Problem Particulates (1451)

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

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested.The investigation is ongoing.

Event Description

A user facility in (b)(6) reported that, during a procedure, a foreign material appeared in the patient's eye.The foreign material was removed and the procedure was completed without any patient injury.The surgery was not prolonged and no additional anesthesia was required.The patient has no complications.

Manufacturer Narrative

A plastic zip-lock bag was returned containing one petri dish with two test chambers and one aqua-green colored irrigation sleeve.The lot and part number could not be determined as the original packaging was not returned.Visual inspection found particulates all over the returned components.Microscopic examination found one small, disc shaped (concaved or arched shaped) particle inside the tip of one of the test chambers.The particle was similar in color to the irrigation sleeve and was soft and squishy.Both the particle and the irrigation sleeve had a speckled appearance.Microscopic examination of the irrigation sleeve found it had scoring or deep gouges on the inside wall of the sleeve shaft, but none of the gouges had fully pierced or perforated the wall.The port windows on the tip were intact and not torn.The particle was sent to an outside testing laboratory for further analysis.A lot number was not provided; therefore the sterilization and lot history records could not be reviewed.The investigation is ongoing.

Manufacturer Narrative

The particle was analyzed using an energy-dispersive spectrometer (eds) equipped scanning electron microscope (sem).Eds analysis indicated the particle consisted primarily of silicon and oxygen.A lesser concentration of carbon was also detected.This is consistent with silicon-containing organic material.The particle was also analyzed using a fourier transform infrared (ftir) spectrometer.The ftir analysis of the particle produced a spectrum consistent with that of silicone rubber.The laboratory analysis indicates the particle is silicone rubber, similar to the material composition of the irrigation sleeve, suggesting the particle is likely a remnant from the manufacturing process as the material is biocompatible.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 most probable root cause was determined to be a component issue.We will continue to monitor reports of this kind.The investigation is complete.

• Brand Name: PHACO ACCESSORY PACK
• Type of Device: UNIT, PHACOFRAGMENTATION
• MDR Report Key: 11974744
• MDR Text Key: 256276678
• Report Number: 0001920664-2021-00070
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• 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: 07/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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