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

Model Number TABLETOP-JAPAN

Device Problem Mechanics Altered (2984)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2019

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 the manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that a probe did not actuate during a procedure.The condition of aspirating is unknown.The procedure was completed after replacing the product with another one.There was no harm to the patient.

Manufacturer Narrative

Additional information provided in d.10., g.1., g.2., h.3., h.6., and h.10.One opened probe was received with a tip protector, in a tray, for the report of did not actuate.The returned sample was visually inspected and found to be non-conforming with foreign material in the port, on the welded cap, and on the needle.The probe was then functionally tested for actuation, aspiration, and cut.The sample was found to be conforming for actuation and cut and was non-conforming for aspiration.The probe sample was 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.Gouge marks were observed at several locations along the inner cutter.The sample was tested with a syringe and resistance was felt.A wire entered the aspiration path but did not go all the way through.The sample was then retested with a syringe and resistance was still felt.The extension was then removed from the coupling and foreign material was observed to be blocking the inner diameter of the cutter inside of the coupling.The foreign material was analyzed using micro ft-ir and sem and the exact identification of the material was unable to be determined.The elemental composition of the material suggests the material most closely matched dried salts.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 complaint evaluation does not confirm that the returned probe had an actuation failure.Unrelated to the reported event, the evaluation indicated that the probe had an aspiration failure.The root cause for the aspiration failure is due to the foreign material in the aspiration path.How and when foreign material was introduced into the aspiration path cannot be determined from this evaluation.The analysis of the material indicated the material to most closely match dried salts, therefore, the foreign material is most likely surgical material from the surgical use of the probe.The returned sample was found to be conforming for actuation and the exact root cause of the foreign material in the aspiration path cannot be determined from the evaluation performed, therefore, no specific action with regard to this complaint was taken by the manufacturing site.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.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: 9350120
• MDR Text Key: 174534652
• Report Number: 2028159-2019-02106
• 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: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• 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: 12/19/2019
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK.