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

Model Number TABLETOP

Device Problems Corroded (1131); Fluid/Blood Leak (1250); Device Emits Odor (1425); Material Puncture/Hole (1504); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2016

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.(b)(4).

Event Description

A nurse reported that the balanced salt solution (bss) had penetrated the system during the course of several procedures.The nurse indicated the issue could be related to the collection bag not being attached to the cassettes or the cassettes were partially leaking.In addition, the insertion filter located below the fluidics module was strongly corroded and it smelled conspicuous.No product samples were retained.There was no harm reported to the patients or the healthcare professionals.No additional information is expected.

Manufacturer Narrative

The lot complaint history was reviewed, this is the second complaint for the finish goods lot; however, the first for this issue.The device history record review indicated the product was released per specifications.The customer provided photographs of the mesh screen on the console.A visual inspection of those photos showed dark blackish residue, likely surgical residue and dried bss from multiple surgeries accumulated over a long time period.No photos showed a cassette or identified fluid leakage from the cassette.No cassette samples were returned for visual or functional testing.While the customer photos showed accumulation of residue on the console, the investigation was unable to verify the exact nature and origin of the residue.As such, without the cassette samples and with the available information, the exact root cause of the reported event could not be established.Potential root causes could be related to surgical technique/setup of cassette or manufacturing related issue, however, this could not be confirmed without sufficient samples.After a thorough investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned.(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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6088277
• MDR Text Key: 59836327
• Report Number: 2028159-2016-05053
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Other Device ID Number: 3.00.61
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 23 GAUGE TOTAL PLUS PACK 5000 CUTS PER MINUTE; BALANCED SALT SOLUTION
• Patient Outcome(s): Other