MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Catalog Number 8065751763

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

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 physician reported observing small metal particles in the anterior chamber of several patients consecutive to phacoemulsification.The number of patients and devices involved are unknown.Additional information has been requested but not received to date.

Manufacturer Narrative

Additional information provided: no sample has been returned for evaluation; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, lot history and device history record reviews could not be conducted.As no sample was returned for evaluation; the condition of the product could not be verified.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.After investigation of this complaint and analysis of complaints of this nature confirm no unfavorable trend for this event.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 8647596
• MDR Text Key: 146630535
• Report Number: 2028159-2019-00942
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION SURGICAL PROCEDURE PAK; CUSTOM-PAK SURGICAL PROCEDURE PACK