MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE CENTURION VISION SYSTEM, HANDPIECE TIP; UNIT, PHACOFRAGMENTATION

Catalog Number 8065750853

Device Problems Component Missing (2306); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2020

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.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported a phacoemulsification tip split in two at the end of a procedure.It performed well in the eye and it was only at the point of removing the tip at the end of the procedure that she noticed half of the tip was missing and they found it in the pink sleeve.There was no harm to the patient.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information provided by the customer who indicated the product sample was destroyed.

Manufacturer Narrative

A sample was not received at the manufacturing site therefore, the condition of the product could not be verified.A review of the device history records traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.A photo attached to the parent complaint was reviewed by the investigation site.The photo shows a blister label with same product and lot number as reported.A sample was not received at the manufacturing site and the device history record review of the lot number provided indicated the product was released to the product¿s acceptable criteria; therefore, the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown; 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.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM, HANDPIECE 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: 10362341
• MDR Text Key: 202688636
• Report Number: 2523835-2020-00156
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K121555
• 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: 08/24/2020

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: 8065750853
• Device Lot Number: 13HXHP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 08/05/2020; 08/18/2020
• Supplement Dates FDA Received: 08/10/2020; 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1