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

Model Number LXT-JAPAN

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2019

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 reported the vitrectomy cutter was dull after starting a procedure.He stopped using it and completed the procedure after replacing the product with another.The condition of the aspiration was not known, there was no harm to the patient.No additional information is expected.

Manufacturer Narrative

One opened probe was received.The returned sample was visually inspected and was found non-conforming with a burr on the cutting edge of the port.The sample was then functionally tested for aspiration, actuation, and cut.The sample was found to be conforming for actuation and was found non-conforming for cut and aspiration.The probe was disassembled and the components inspected.No/minimal 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 a couple of other locations along the inner cutter.The sample was tested with a syringe and slight resistance was felt.A wire was inserted through the aspiration path to remove the interference.The sample was retested with a syringe and no resistance was felt.The sample was retested for aspiration with the probe driver and was able to aspirate.The initial aspiration test failed due to an interference in the aspiration path and once the interference was removed the probe was able to aspirate.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 is one additional complaint associated with the component lots for the reported issue.The complaint evaluation confirmed that the probe had a cut issue.Unrelated to the reported event, the evaluation also indicated that the probe had an aspiration issue.The most likely root cause for the poor cutting is the burr observed on the cutting edge of the port.The root cause for the aspiration issue is due to foreign material in the aspiration path.How and when foreign material was introduced into the aspiration path cannot be determined from this evaluation.The burr on the cutting edge of the port was non-conforming; therefore, review training has been performed with the applicable production personnel to raise awareness of this issue and is documented on the facility¿s review training form.No action was taken by the manufacturing site in regards to the observed aspiration non-conformance since the exact root cause could not be determined from the evaluation.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.An acceptable quality limit (aql) inspection is also performed and includes inspection for burrs on probe needles.The associated probe component lots met the aql release inspection criteria.Any non-conformances found are removed from the lot and scrapped.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: 8535892
• MDR Text Key: 142753549
• Report Number: 2028159-2019-00716
• 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: 09/16/2019

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: LXT-JAPAN
• Device Catalogue Number: 8065752043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Manufacturer Received: 04/19/2019
• Initial Date FDA Received: 04/22/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK