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

Model Number TABLETOP-JAPAN

Device Problem Mechanics Altered (2984)

Patient Problem No Consequences Or Impact To Patient (2199)

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.A product sample has been shipped; however, it has not been received for evaluation at the manufacturing site.(b)(4).

Event Description

A customer reported poor cutting of the probe at the start of the procedure.Aspiration function is unknown.The product was replaced and procedure completed with no patient harm.

Manufacturer Narrative

One opened probe was received with a tip protector, in a tray, for the report of poor cutting.The returned was visually inspected and was found to be conforming.The sample was then functionally tested for actuation, aspiration, and cut.The sample was found to be conforming for aspiration and was non-conforming for actuation, and cut.The probe was disassembled and the components inspected.No/minimal wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.The inner cutter pulled out of the coupling.No presence of adhesive was observed on the inner cutter.The inner cutter / coupling adhesive bond fillet was visually inspected and was found to be conforming.No wear marks were observed at the bend area.A review of the device history record 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 for device component lots traceable to the reported lot number indicates there is one additional complaints associated with the component lots for the reported issue.The evaluation confirms that the returned probe had a cut issue and also indicated that the probe had an actuation issue.The root cause for the observed cut and actuation issues is the separation of components within the probe.It appears that at the beginning of surgical use the adhesive bond failed causing the inner cutter to detach from the coupling.An internal investigation was completed and identified areas to implement additional process controls within the manufacturing process to reduce the frequency of probe complaints for detachments of the inner cutter from the coupling.The procedure was reviewed and found to provide adequate instructions to operators for the bonding process of the inner cutter to coupling.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed for this reported event.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION 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: 8687905
• MDR Text Key: 147880571
• Report Number: 2028159-2019-01056
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• 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: 08/27/2019

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 Model Number: TABLETOP-JAPAN
• Device Catalogue Number: 8065751817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: 08/22/2019
• Supplement Dates FDA Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK