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

Catalog Number 8065753048

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

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 during multiple ocular procedures, there were bubbles in the pipes and reflux issues.Event details are unknown.There were no consequences for patients.Additional information has been requested.This is 3 of 4 reports being filed from this facility.

Manufacturer Narrative

Additional and corrected information has been provided in b.5.The manufacturer internal reference number is: (b)(4).

Event Description

Further information was received from the company representative indicating the "bubble problem" is ongoing and occurs randomly during cataract procedures and retinal procedures.The reflux problems have resolved.There have been no patient incidents.During troubleshooting, it was found that the level of compressed air delivered by the facility was not constant, and is below the recommended system specifications.

Manufacturer Narrative

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

Event Description

Additional information has been requested and clarification was received indicating that there were bubbles in the tubes and reflux was too strong during multiple ocular procedures in (b)(6) 2019.The bubbles occurred during all stages in the patient's eye.The number of events are unknown.The procedures were completed with difficulty.There were no system messages and no system alarm.

Manufacturer Narrative

The company service representative examined the system but was unable to replicate the reported event.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The system was found to meet specifications.Therefore, the root cause of the reported event cannot be determined conclusively.As the customer did not retain the consumable finished goods lot number, device history record (dhr) and lot history could not be reviewed.All lots are verified that all required tests have been performed and all acceptance criteria are met prior to release.No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.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: 9514242
• MDR Text Key: 177612633
• Report Number: 2028159-2019-02319
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065753048
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK.; DUOVISC VISCOELASTIC SYSTEM.