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

Catalog Number 8065750833

Device Problem Output below Specifications (3004)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2016

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 customer reported that during a cataract extraction with intraocular lens implant procedure the handpiece did not have phacoemulsification power.The case was completed using an alternate handpiece.There was no harm to the patient.

Manufacturer Narrative

The system and handpiece were examined.There was no problem found with the handpiece.The associated system was verified to meet specifications.The system was tested and found to meet product specifications.A review of complaints for the last 24 months did not indicate any additional related reports for this phaco handpiece.Based on qa assessment, the product met specifications at the time of release.A review of the manufacturing records did not reveal any related non-conformity during manufacturing for this product.The phacoemulsification handpiece was found to exhibit no issues.Therefore, the root cause of the reported event cannot be determined conclusively.(b)(4).

Manufacturer Narrative

The phaco handpiece was received for evaluation.A visual assessment of the returned sample found no visual nonconformities.The returned handpiece was connected to a calibrated system.The handpiece tuned successfully and completed a five minute burn-in with the system set at 100% ultrasonic and torsional power.The handpiece was then found to meet specifications when connected to the calibrated for stroke testing on the ultrasonic and torsional movements.Review of the data indicates that there were 3 procedures performed with this handpiece.The last recorded data displayed no tuning issues.The returned handpiece was found to meet specifications.Based on the information obtained, the root cause of the reported event cannot be determined conclusively.(b)(4).

• Brand Name: INFINITI VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6147598
• MDR Text Key: 61869442
• Report Number: 2028159-2016-05566
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2020
• Device Catalogue Number: 8065750833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: OZIL TORSIONAL PHACO HANDPIECE
• Patient Outcome(s): Other