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

Model Number LXT-JAPAN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2019

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 the tip of a cutter was detached in the patient's eye during a procedure.Surgeon felt like the outer cylinder and the shaft part moved about 1 centimeter forward in the patient's eye when stepping on the footswitch.The time cutter used during this event was about 10 minutes.The tip was removed from the patient's eye and the surgery was completed after replacing the product with another one.There was no patient harm.

Manufacturer Narrative

Two opened probes (only one of which is related to the complaint) and two unopened opened probes were received in trays along with other items for the report of detached tip during surgery.The related opened probe was visually inspected and found to be non-conforming with the tip of the inner cutter visible in the port and orange/brown foreign material in the port.The two unopened probes were also visually inspected and found to be conforming.No detachment of any portion of the needle was indicated during the evaluations of all three samples.The opened probe was then disassembled and the components inspected.No/minimal wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Wear marks and gouge marks were observed at a couple locations along the inner cutter.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.The sample evaluation did not confirm any portion of the needle was detached, therefore the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as no portion of the probe needle was confirmed to be detached.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformance's found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No further actions are required.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: 9125761
• MDR Text Key: 165611060
• Report Number: 2028159-2019-01752
• 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: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LXT-JAPAN
• Device Catalogue Number: 8065752043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 09/26/2019
• Supplement Dates Manufacturer Received: 12/09/2019
• Supplement Dates FDA Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK