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

Model Number TABLETOP-JAPAN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2019

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 surgeon that the fixation of handle part of probe was weak and the handle became detached during a procedure.The same event occurred again after replacing the product with another one.The procedure was completed after replacing the product with a third one.There was no harm to the patient.

Manufacturer Narrative

Additional information provided: probe engine evaluation: the returned sample was visually inspected and found non-conforming with the probe broken at the front and rear housing.The probe was disassembled and the components inspected.Nominal 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 were observed at the bend area of the inner cutter.Gouge marks were observed at one location along the inner cutter.Adhesive was observed on the front and rear housings.A photo of two probes is attached to the parent file and has been reviewed by the manufacturing site.The photo shows one probe with the rear shell detached and one probe with the engine assembly broken/detached.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 for device component lots traceable to the reported lot number indicates there are no additional complaints associated with the component lots for the reported issue.The complaint investigation confirms that the probe engine housing components were separated due to an adhesive bond breakage between the engine housing components.The root cause for the separation of components cannot be determined from this evaluation.An internal capa investigation was completed to determine the reason for the engine housing component separation.The investigation concluded that adhesive bond breakage does not occur when the product is used per the supplied directions for use.How and when the engine housing component separation occurred was not able to be determined from this evaluation, therefore, specific action with regards to this complaint cannot be taken.Probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed for this reported event.Probe rear shell evaluation: the lot complaint history was reviewed.This is the second complaint for the finished goods lot; however, it is the first complaint for this issue for this lot.The device history record shows the product was released per specifications.Upon visual inspection the probe rear shell was detached from the engine.Further inspection found no damage on the probe shell and was intact indicating it was likely not mounted properly during final assembly.The rear shell was mounted onto the probe engine and could fully engage as observed on the rear shell, which could be placed on the probe engine securely.The vitrectomy probe rear shell is meant to improve the ergonomics of the handpiece and does not affect the probe's performance or functionality.The root cause of the customer's complaint is related to an error during the final assembly phase of the probe.The rearshell was not mounted and fully engaged to the probe engine during assembly.Each probe assembly is visually inspected for any observed defects during assembly to mitigate this issue from occurring.Action will not be taken for this occurrence.After investigation of this complaint and analysis of complaints of this nature confirm no unfavorable trend for this event and this observed issue is occurring at a low level.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: 8839256
• MDR Text Key: 152637621
• Report Number: 2028159-2019-01395
• 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: 11/15/2019

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: TABLETOP-JAPAN
• Device Catalogue Number: 8065751817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/29/2019
• Supplement Dates Manufacturer Received: 10/25/2019
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK