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

Model Number TABLETOP-JAPAN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2018

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.A product sample has been received by the manufacturer and it is awaiting evaluation.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported, during a procedure,the cutter suddenly stopped aspirating and he observed the beveled tip was almost detached and upon removing the cutter from the eye, it pulled out the trocar.The procedure was completed by replacing the product.There was no harm to the patient, no additional information is expected.

Manufacturer Narrative

Additional information provided.One opened probe was received with a tip protector in a tray, along with a trocar cannula/hub assembly, for the report of broken tip, could not aspirate, and pulled out trocar.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 is one additional complaint associated with the lot for the reported issue.Photos of the product are attached to the parent file and have been reviewed by the investigation site.The photos confirm that the tip of the probe needle is broken at the port.The system's log was reviewed by the manufacturing site; the lot number of the probe identified in the log does not match the reported lot number of the complaint file the returned sample was visually inspected and found non-conforming with the probe needle broken at the port.Functional testing could not be performed due to the tip being broken off.The probe was disassembled and the components inspected.Excessive wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Gouge marks were observed at the bend area, cutting edge, and several other locations along the inner cutter.The complaint evaluation confirmed that the probe had a broken tip at the port.The complaint evaluation was unable to verify whether or not the returned probe would have functionally fit through a trocar, however the damage seen to the tip during evaluation would have made it difficult for the probe to enter into a trocar.Because of the damaged tip, functional aspiration testing could not be performed in order to determine if the probe was able to aspirate or not.The exact root cause for the broken tip cannot be determined from this evaluation.The most likely contributing factor to the broken tip at the port is excessive surgical use of the probe.The vitrectomy portion of the procedure is typically less than 20 minutes and it appears that the probe had experienced a use much greater than this typical timeframe.An internal investigation has been initiated to further evaluate the cause of probe tip breakage at the port.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints will continue to be reviewed and closely monitored at regular intervals for any significant adverse trends.No additional action is required at this time.(b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7774071
• MDR Text Key: 117001035
• Report Number: 2028159-2018-01690
• 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: 11/05/2018

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: TABLETOP-JAPAN
• Device Catalogue Number: 8065751817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/10/2018
• Supplement Dates Manufacturer Received: 10/15/2018
• Supplement Dates FDA Received: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK
• Patient Outcome(s): Other