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

Catalog Number 8065750469

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 01/11/2018

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.(b)(4).

Event Description

A healthcare professional reported that during a surgical procedure the handpiece did not work.The handpiece tuned as normal.The case was completed using an alternate handpiece.Additional information was requested and received.

Manufacturer Narrative

The customer reported that the phaco handpiece did not work during surgery.The phaco handpiece was switched out to complete the procedure.There was no patient harm.The phaco handpiece was received and a visual assessment of the returned sample revealed no obvious nonconformity.The phaco handpiece was connected to a calibrated system.The phaco handpiece tuned successfully and completed a five minute burn-in test with the system set at 100% ultrasonic and torsional power.The phaco handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements which found the phaco handpiece to meet specifications per manufacturing test procedure (mtp).The phaco handpiece was manufactured on march 8, 2012.Based on qa assessment, the product met specifications at the time of release.The phaco handpiece was found to meet specifications.The root cause is unable to 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, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7296867
• MDR Text Key: 101124208
• Report Number: 2028159-2018-00372
• 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: 06/01/2018

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
• Other Device ID Number: 8065750469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/26/2018
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other