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

Catalog Number 8065750833

Device Problems Device Inoperable (1663); Failure to Cut (2587)

Patient Problem No Code Available (3191)

Event Type  Injury  

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 procedure, intelligent phacoemulsification became active and the pre set settings went up to 40.The phacoemulsification handpiece was not phacoing.They attempted to use a second handpiece, the second handpiece did not work as well as expected and the case became difficult.A vitrector and capsular ring was required.The vitrector did not activate the set up screen, they reprimed the handpiece and replaced the cassette.The virector did not cut.Another vitrector was opened and again there was no set up screen, they had to reprime the vitrector again, the vitrector would not cut.The case was completed with a suture.

Manufacturer Narrative

The system was examined and the reported event was not replicated.The system was tested and found to meet product specifications.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.Based on qa assessment, the product met specifications at the time of release.There was no information concerning the phaco handpiece or the vitrectomy probe available.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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7400974
• MDR Text Key: 104526406
• Report Number: 2028159-2018-00691
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750833
• Other Device ID Number: 380657508334
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 04/05/2018
• Supplement Dates Manufacturer Received: 06/12/2018
• Supplement Dates FDA Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2012
• 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
• Patient Outcome(s): Other; Required Intervention