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

Catalog Number 8065751761

Device Problems Device Alarm System (1012); Overheating of Device (1437); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2020

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 healthcare professional reported handpiece displayed system messages, performance was not efficient and was heating.The cataract with intraocular lens implant was completed with an alternate system.There was no harm to the patient.

Manufacturer Narrative

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

Event Description

Additional information received states that this handpiece had no phaco, however, did not heat up.

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.The root cause cannot be determined conclusively the manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION 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: 9914195
• MDR Text Key: 187545015
• Report Number: 2028159-2020-00313
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2020

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: 8065751761
• Device Lot Number: 138TCF
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 06/11/2020; 06/29/2020
• Supplement Dates FDA Received: 06/30/2020; 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LEGION SYSTEM