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

Model Number TABLETOP

Device Problems Device Alarm System (1012); Overheating of Device (1437)

Patient Problems Visual Impairment (2138); Eye Burn (2523)

Event Date 08/05/2020

Event Type  Injury  

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 biomedical engineer reported the handpiece overheated during a cataract extraction with intraocular lens implant procedure.The patient experienced a corneal burn.The surgeon had difficulty in completing the case.No system messages were displayed.The case was extended by an hour and a half.The procedure was completed using an alternate handpiece.Additional information has been received indicating the patient experienced a wound leak at the burn site.Three sutures were needed to close the wound.The patient has developed corneal astigmatism.

Manufacturer Narrative

The company service representative examined the system and no problems were found.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The system was found to meet specifications; therefore, the root cause of the reported events cannot be determined conclusively.Corneal burn is an issue that is occasionally reported with cataract surgery.According to the pennsylvania patient safety advisory abstract: preventing corneal burns during phacoemulsification, march 2010, vol.7, no.1: 23-25, most corneal burns can be traced to issues related to surgical technique and not to malfunctioning equipment.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: 10575154
• MDR Text Key: 208188266
• Report Number: 2028159-2020-00765
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OZIL TORSIONAL PHACO HANDPIECE; OZIL TORSIONAL PHACO HANDPIECE
• Patient Outcome(s): Required Intervention
• Patient Age: 100 YR