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

Catalog Number 8065750833

Device Problem Difficult to Insert (1316)

Patient Problem Rupture (2208)

Event Date 12/05/2016

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.(b)(4).

Event Description

A customer reported that a patient experienced a posterior capsular rupture during a procedure.The intraocular lens was unable to be placed in the eye.Additional information has been requested but none has been received.

Manufacturer Narrative

No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.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.The system was manufactured on june 16, 2008.Based on qa assessment, the product met specifications at the time of release.Posterior capsule tear is an issue that is occasionally reported with cataract surgery.However, a review of the complaint trends shows that the frequency reported is within known levels for this event.A root cause cannot be determined conclusively.The manufacturer internal reference number is: (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: 6277992
• MDR Text Key: 65771189
• Report Number: 2028159-2017-00379
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 8065750833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2008
• 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
• Patient Age: 81 YR