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

Catalog Number 8065751763

Device Problems Obstruction of Flow (2423); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

The sample has been received and in-house evaluation is in progress.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 customer reported that during surgery, the i/a handpiece was clogged.Foreign material, "ball", was found in the ia tip.The case was completed without patient harm.

Manufacturer Narrative

The foreign material was received and a visual assessment of the returned sample showed a small foreign material (smaller than 1x1mm) secured under a tape.The sample was sent for material analysis; conclusion pending.The i/a tip lot number (l/n) was not provided and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

A round opaque particle was approximately 260um in diameter and was found to be 54.24% match with bac (benzalkonium chloride).Further evaluation identified it as mostly carbon and chlorine.However, the exact identification of the particle is unknown.The root cause cannot be determined conclusively.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: 8540374
• MDR Text Key: 143025807
• Report Number: 2028159-2019-00731
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2019

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: 8065751763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/23/2019
• Supplement Dates Manufacturer Received: 08/02/2019; 09/04/2019
• Supplement Dates FDA Received: 08/06/2019; 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CEN FMS PACK,ACT,.9U 45 BAL; CENTURION OZIL HP
• Patient Age: 57 YR