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

Catalog Number 8065750469

Device Problem Suction Failure (4039)

Patient Problems Visual Disturbances (2140); Eye Burn (2523)

Event Date 02/03/2020

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 surgeon reported at the beginning of the phacoemulsification (phaco) phase of a cataract extraction with intraocular lens implant procedure the was no aspiration with the handpiece.After ten seconds the surgeon realized the corneal tunnel was burned.The handpiece was exchanged and the case completed.The patient required six sutures.Twenty diopters of astigmatism was induced.The surgeon continues to remove sutures but astigmatism remains.Additional information has been received.Eight sutures were required to close the wound.There were no corneal opacities on the optical axis.On post operative day one the iris was noted have engaged the incision.This is one of three reports from this facility.

Manufacturer Narrative

The phaco handpiece was not returned for evaluation.The phaco handpiece manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported events could not be confirmed.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.Based upon the information provided the root cause of the reported event cannot be determine conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 10363370
• MDR Text Key: 201673510
• Report Number: 2028159-2020-00588
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K112425
• 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: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750469
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFINITI VISION SYSTEM
• Patient Outcome(s): Required Intervention