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

Catalog Number 8065750833

Device Problem Mechanical Jam (2983)

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 the system locked before surgery.

Manufacturer Narrative

The company service representative examined the system and was able to replicate and confirm the reported event.The nonconforming host controlled area network (can) controller printed circuit board (pcb) was replaced.As a preventative measure, the host card reader was replaced.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 root cause of the reported event can be attributed to a nonconforming host controlled area network (can) controller printed circuit board (pcb).The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information d.10., h.3., h.6.And h.10.The host controlled area network (can) controller printed circuit board (pcb) was received for evaluation.The returned sample was installed into a calibrated system hotbed.The system was able to boot-up without issues.The power up test was performed.The system was able to load and prime the cassette without issue.The host controlled area network (can) controller printed circuit board (pcb) functioned as intended; therefore the root cause of the reported event can be attributed to internal wear/reliability issues within the system.The root cause of the reported event can be attributed to internal wear or reliability issues within the system.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI 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: 8707546
• MDR Text Key: 148547198
• Report Number: 2028159-2019-01109
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2020

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 Catalogue Number: 8065750833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 08/26/2019; 05/15/2020
• Supplement Dates FDA Received: 09/16/2019; 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1