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

Model Number TABLETOP

Device Problem Device Inoperable (1663)

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

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 console table top illuminator was not working.The auxiliary illuminator was used to complete the case.There was no patient harm.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The company service representative examined the system, but was unable to replicate the reported event.However, the company service representative replaced the illuminator module as a preventive measure.The system was then tested and met all product specifications.The system was manufactured on december 6, 2012.Based on qa assessment, the product met specifications at the time of release.The illuminator module and xenon lamp were received and a visual assessment of the returned sample showed that the table top illuminator had a cracked aspheric collimating lenses.The sample lamp was installed into the sample illuminator, which was then installed into a calibrated system and booted up without any error.Lumens output from ports 1 and 2 were measured to meet specifications.Due to the visual nonconformity noted before functional testing, the sample was disassembled to find cracked aspheric collimating lenses.The illumination output on both ports were found to meet specification, but cracked lenses can reduce the illumination output.The root cause can be attributed to the cracked aspheric collimating lenses.An internal investigation has been opened to address cracked lenses inside illuminator modules.(b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7264769
• MDR Text Key: 99944581
• Report Number: 2028159-2018-00277
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2018

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 Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Other Device ID Number: 8065751150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/12/2018
• Supplement Dates Manufacturer Received: 03/05/2018; 04/10/2018
• Supplement Dates FDA Received: 03/30/2018; 04/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2012
• 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 Outcome(s): Other