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

Catalog Number 8065750469

Device Problem Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2021

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 cataract extraction procedure the phacoemulsification handpiece did not have phaco power on a grade 4 cataract.The surgeon adjusted settings.Additional information has been requested but not received.

Manufacturer Narrative

The phacoemulsification (phaco) handpiece was not returned for evaluation.The phaco handpiece manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported event could not be confirmed.The root cause of the reported event cannot be determined 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: 11292674
• MDR Text Key: 232027569
• Report Number: 2028159-2021-00129
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

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: 8065750469
• Device Lot Number: 1390V6
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1