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

Model Number TABLETOP

Device Problem Device Inoperable (1663)

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

Event Date 12/27/2017

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 nurse reported that the tip stopped working at the middle of a vitrectomy procedure.The condition of aspiration is unknown.The procedure was completed in the same day.The reporter informed that there was patient harm and the patient has recovered; the harm was not clarified.Additional information and product sample have been requested.

Manufacturer Narrative

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 was one additional complaint associated with the lot for the reported issue.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.A sample was not returned and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore, the root cause for customer complaint issue 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.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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 four additional complaints associated with the lot for the reported issue.The returned sample was visually inspected and was found conforming.The probe was then functionally tested for aspiration, actuation, and cut.The sample was found conforming for actuation and cut and non-conforming for aspiration.The probe sample 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.Gouge marks were observed at the bend area and several other locations along the inner cutter.The sample was tested with a syringe and resistance was felt.A wire enters the aspiration path but does not go through.The sample was retested with a syringe and resistance was felt.The aspiration path is blocked.The complaint evaluation confirms the probe sample had an aspiration issue.The root cause for the aspiration issue is due to occlusion of the aspiration path.How and when the aspiration path became occluded cannot be determined from this evaluation.The returned sample was found to be conforming for actuation and cut, therefore an issue as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No specific action with regard to this complaint was taken by the manufacturing site because the exact root cause of the aspiration issue cannot be determined from this evaluation.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints will be continued to be 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, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7209938
• MDR Text Key: 98091759
• Report Number: 2028159-2018-00172
• 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,Followup
• Report Date: 12/28/2018

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: Physician
• Device Expiration Date: 06/10/2020
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Manufacturer Received: 12/27/2017
• Initial Date FDA Received: 01/22/2018
• Supplement Dates Manufacturer Received: 03/22/2018; 12/03/2018
• Supplement Dates FDA Received: 04/03/2018; 12/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK
• Patient Outcome(s): Other
• Patient Age: 26 YR