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

Catalog Number 8065751763

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2018

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 nurse reported that during a cataract extraction procedure they could not get the anterior vitrectomy cutter to work.There was no cutting or aspiration with the probe, and no corresponding noise of the pump working.As the footswitch was depressed the screen displayed the cute rate moving but there was no sound.The case was completed using an alternate system.Additional information has been requested and received.

Manufacturer Narrative

Additional information has been provided.The customer reported that the vitrectomy cutter was not working with the system.The case was completed using an alternate system.The system was manufactured on december 16, 2016.Based on qa assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported event could not be confirmed.The 23-gauge ultra-vitrectomy probe was not returned for evaluation for the report of no cutting or aspiration; therefore, the condition of the product could not be verified.A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there are no additional complaints associated with the lot for the reported issue.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformances found are removed from the lot and scrapped.The root cause of the reported event 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, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7510118
• MDR Text Key: 108361818
• Report Number: 2028159-2018-00995
• 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: 08/01/2018

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
• Other Device ID Number: 380657517633
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/14/2018
• Supplement Dates Manufacturer Received: 07/17/2018
• Supplement Dates FDA Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASSY,SHIP,CENT ULTRAVIT 23GA
• Patient Outcome(s): Other