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

Model Number ASKU

Device Problems Complete Blockage (1094); Noise, Audible (3273)

Patient Problem Intraocular Pressure Decreased (4468)

Event Date 10/01/2020

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 customer reported that during a procedure, the patient's intraocular pressure decreased, a small ding noise was heard, and the system blocked.No phases of the system were available.Additional information has been requested.

Manufacturer Narrative

It is unknown which system is related to the event.The company service representative examined the three (3) systems and was not able to confirm or replicate the reported events.The systems were then tested and met all product specifications.The manufacturing device history record (dhr) was reviewed for each of the three (3) systems.Based on qa assessment, the products met specifications at the time of release.The cassette was not returned for evaluation.The systems were found to meet specifications; therefore, the root cause of the reported events 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: 10755853
• MDR Text Key: 215308981
• Report Number: 2028159-2020-00888
• 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
• Report Date: 12/24/2020

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 Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 12/24/2020
• Patient Sequence Number: 1
• Treatment: CEN FMS PACK,ACT,.9U 45 BAL.