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

Model Number LXT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Endophthalmitis (1835); Loss of Vision (2139); Vitrectomy (2643)

Event Date 04/14/2019

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 surgeon reported a patient had "vision disappear" and was diagnosed with acute suppurative endophthalmitis four days postoperatively in the left eye following a 25 gauge vitrectomy, retinal laser treatment and membrane peel procedure.A vitreous puncture sampling, injection, anterior chamber puncture and a vitreous cavity lavage was performed in the emergency department.Staphylococcus lugdunensis bacteria was cultured and treated with intravenous antibiotic and anti-inflammatory agent.The inflammation was controlled and the vision is gradually improving.

Manufacturer Narrative

No probe or trocar samples have been returned for evaluation.Photo attached to the parent complaint was reviewed by the manufacturing site.Photo shows a pouch with a small part tray with three trocar assembly and the label confirms the reported product and lot numbers.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there are no additional complaints associated with the lot for the reported probe or trocar issues.No samples were returned and the device history record reviews of the lot number provided indicated the probe and trocar products were processed and released according to the product¿s acceptable criteria, therefore, the root cause for the customer complaint issues cannot be determined.The exact root cause for this complaint is unknown as no sample was returned; therefore, specific action with regards to this complaint cannot be taken.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.An acceptance quality inspection is performed to ensure trocar product meets release acceptance criteria.Any non-conformances found are removed from the lot and scrapped.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION 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: 8611897
• MDR Text Key: 145133925
• Report Number: 2028159-2019-00879
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• 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: 08/15/2019

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 Model Number: LXT
• Device Catalogue Number: 8065751550
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2019
• Initial Date FDA Received: 05/15/2019
• Supplement Dates Manufacturer Received: 07/25/2019
• Supplement Dates FDA Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADRENALINE HYDROCHLORIDE; BALANCED SALT SOLUTON; CONSTELLATION ULTRAVIT PROBE; EDGEPLUS VALVED ENTRY SYSTEM; ADRENALINE HYDROCHLORIDE; BALANCED SALT SOLUTON; CONSTELLATION ULTRAVIT PROBE; EDGEPLUS VALVED ENTRY SYSTEM
• Patient Outcome(s): Other
• Patient Age: 60 YR