MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE PHACO TIP; UNIT, PHACOFRAGMENTATION

Catalog Number ASKU

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A surgeon reported that they observed a very smart chip of metal in a patient's eye after a procedure.Customer indicated that the phacoemulsification tip vibrations induced a small piece of metal tip falling off into patient eye.The metal chip was not removed from the patient's eye.Customer indicated there are not plans to removed metal piece at this moment.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report of small chip of metal seen after the surgery in patients eye and remained in eye; however, the attached customer photo confirm the reported issue of a particle in the eye, the source and composition of the particle cannot be determined from the photo attached.The reported event of phaco broken/cracked cannot be confirmed on the photo attached.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The report of particle in the eye is confirmed based on the photo attached to parent complaint, the source and composition of the particle cannot be determined from the photo attached.The reported event of phaco broken/cracked cannot be confirmed on the photo attached.However; because a sample was not received at the manufacturing site and no lot information was provided, the root cause for the customer complaint issue cannot be determined the cause of the reported event cannot be determined with the information obtained; therefore, specific action with regards to this complaint cannot be taken.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: PHACO TIP
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• MDR Report Key: 10755007
• MDR Text Key: 215273930
• Report Number: 2523835-2020-00234
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K161794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

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 Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/22/2021
• Patient Sequence Number: 1
• Treatment: SN60WF.210,
• Patient Age: 72 YR