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

Model Number TABLETOP

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Toxicity (2333)

Event Date 06/05/2018

Event Type  Injury  

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 healthcare professional reported that a patient developed toxic anterior segment syndrome (tass) postoperatively.Additional information has been requested.

Manufacturer Narrative

The most common causes of toxic anterior segment syndrome (tass) are identified as follows in order of prevalence: inadequate flushing of phaco, irrigation/aspiration handpieces and cannulated equipment, use of enzymatic cleaners and detergents, use of reusable cannulas, inadequate cleaning of instruments, use of preserved epinephrine, reuse of single use devices, use of tap water with no sterile water final rinse, inadequate personnel or trays to allow proper preparation of instruments, no immediate cleaning allowing ophthalmic viscoelastic device (ovd) and surgical solutions to dry on instruments, use of preserved medicines in the eye, reuse of tubing for flushing, latex bulbs for irrigation, not training, no terminal sterilization, instruments stored on towels, touching of intraocular lens (iol) or patient contact areas of instruments with gloved hands, off-label use of lidocaine gel, poor instrument maintenance, autoclave residue, rust, particulates, lint, use of powdered gloves, additives added to balanced salt solution against directions for use (dfu) , improper use of prep solutions, detergents and cleaners, failure to follow manufacturer¿s directions for use, including no air flush, use of unapproved enzymatic cleaners, use of postoperative ointment in clear corneal cases, povidone-iodine placed in the eye at the end of procedures, incorrect concentration of detergents and enzymatic cleaners.The systems are closed systems.They are operated with a sterile single use consumable cassette, which is designed to isolate the patient fluid path from the console itself.Any surgical instrumentation that would come into contact with the patient would be cleaned and autoclaved by the user prior to surgery, per standard industry practices and company directions for use (dfu).The proper cleaning and sterilization of ophthalmic surgical instruments can help prevent the occurrence of tass.These findings continue to validate the need to follow the recommendations detailed in the dfus, aorn recommended practices, and the ascrs tass task force guidance document.There is no evidence that the design or manufacturing of the system or phaco handpiece contributed to the reported event.No service request (sr) was opened regarding this report.However, it should be noted that since this reported event, on july 8, 2018, an sr was opened (unrelated to this reported event) where the system was tested and found to meet specifications.The system was manufactured on march 15, 2012.Based on qa assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported event could not be confirmed.The root cause of the reported event cannot be determined conclusively.(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
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7643263
• MDR Text Key: 112541987
• Report Number: 2028159-2018-01343
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Other Device ID Number: 380657511501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: 09/04/2018
• Supplement Dates FDA Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other