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

Catalog Number 8065750833

Device Problems Gas/Air Leak (2946); Protective Measures Problem (3015)

Patient Problem Capsular Bag Tear (2639)

Event Date 06/19/2019

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 nurse unit manager reported that during a long cataract surgery, the screen alarmed with message "low pressure".The nurses observed that the balanced salt solution (bss) bottle was empty so the surgeon paused and the bottle was changed.The procedure was continued and soon after, the surgeon observed bubbles in the anterior chamber.The patient experienced a posterior capsular tear.An anterior vitrectomy was performed and further vitrectomy procedure is required.It was reported that the nurses could visibly see the air bubbles in the infusion line.

Manufacturer Narrative

No sample has been returned for evaluation; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.All lots are inspected and every lot is verified that all required tests have been performed and all acceptance criteria were met.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 8772639
• MDR Text Key: 150449882
• Report Number: 2028159-2019-01252
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K120912
• 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: 10/10/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065750833
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 09/18/2019
• Supplement Dates FDA Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFINITI SURGICAL PROCEDURE PAK; INFINITI SURGICAL PROCEDURE PAK
• Patient Outcome(s): Required Intervention