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

Catalog Number 8065750469

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 06/29/2020

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 customer reported the phacoemulsification handpiece got hot prior to a surgical procedure.There was not patient involvement.Completion of case is unknown.Additional information has been received indicating the handpiece got hot prior to a cataract extraction with intraocular lens implant procedure.The case was initiated and completed using an alternate handpiece.There was no patient harm.

Manufacturer Narrative

The phacoemulsification (phaco) handpiece (hp) was received and a visual assessment of the returned sample found no visual nonconformities.The returned 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.During the burn-in test, the temperature of the hp was measured and was found to be within product specifications.The phaco handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements, which found the handpiece to meet product specifications.The phaco handpiece manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The phaco handpiece was found to meet product specifications; therefore, the root cause of the reported event cannot be determined conclusively.The company service representative examined the system was not able to confirm or replicate the reported event.The system was then tested and met all product specifications.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: 10277125
• MDR Text Key: 199658583
• Report Number: 2028159-2020-00533
• 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: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFINITI VISION SYSTEM