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

Model Number TABLETOP

Device Problems Energy Output Problem (1431); Mechanics Altered (2984)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2019

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 customer reported that the fragmatome handpiece had poor cutting and the laser setting was higher than usual.The case was completed using the same equipment.There was no patient harm.

Manufacturer Narrative

The company service representative examined the system but was unable to replicate the reported event of the laser power being low.The company service representative tested and verified the laser power output and found it to meet product specifications.The company service representative was able to replicate the reported event of the sm.The company service representative observed sm (illuminator ballast thermo-cut-off has been triggered.Illuminator functions will be disabled.) in the system and was unable to clear it.The root cause of the sm is likely due to a nonconforming table top illuminator.However, a replacement illuminator cannot be replaced at that time.The company service representative tested and verified the auxiliary illuminator and found it to perform as intended.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The fragmatome handpiece was received and a visual assessment of the returned sample found no nonconformities.The returned sample was connected to a calibrated system.The handpiece tuned successfully and completed a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.The handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements, which found the handpiece did not meet product specifications.Disassembling the handpiece revealed a twisted low electrode and high electrode.The customer reported event was confirmed, which found twisted low and high electrodes to cause the torsional stroke length of the fragmatome handpiece to not meet product specifications.The fragmatome handpiece manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event of the low laser power cannot be determined conclusively as the system was found to meet specifications.The root cause of the reported event of sm displayed cannot be determined conclusively.The root cause of the fragmatome handpiece was not cutting as expected and had low power, can be attributed to a twisted low electrode and high electrode.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
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8809507
• MDR Text Key: 151709794
• Report Number: 2028159-2019-01323
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 74 YR