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

Catalog Number 8065750469

Device Problems Overheating of Device (1437); Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

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.(b)(4).

Event Description

A nurse reported that during a cataract extraction procedure the phacoemulsification (phaco) handpiece got hot and had no power.Additional information has been requested and received which indicated.There was no system message displayed.The handpiece was exchanged and the procedure was completed with no impact to the patient.

Manufacturer Narrative

Additional information has been provided in d.4., d.9., h.3., h.6.And h.10.Corrected information has been provided in h.6.Patient code.The phaco handpiece was received and a visual assessment of the returned sample found no 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.The temperature of the phaco handpiece shell was measured and was found to meet specifications.The phaco handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements, which found the torsional stroke measurement of the phaco handpiece did not meet product specifications.Disassembling the handpiece revealed moisture ingress within the electrode chamber.There was no problem found with the returned phaco handpiece during testing, as related to the reported event of the handpiece getting hot.The reported event of no phaco power was confirmed through dtf testing which found the phaco handpiece did not meet specifications for the torsional stroke measurement.Disassembling the phaco handpiece revealed moisture ingress within the electrode chamber, however, how or when the moisture entered the phaco handpiece remains inconclusive.The phaco handpiece manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The returned handpiece was found to exhibit no problems as related to the reported event of the handpiece getting hot; therefore, the root cause of the reported event cannot be determined conclusively.The root cause of the reported event of no phaco power can be attributed to moisture ingress causing a short circuit from the high electrode to ground; however, how or when moisture entered the handpiece remains inconclusive.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: 11103549
• MDR Text Key: 225816384
• Report Number: 2028159-2021-00001
• 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: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/01/2021
• 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: 01/05/2021
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1