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

Model Number TABLETOP

Device Problems Failure to Cut (2587); Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A product sample has been received by the manufacturer and it is awaiting evaluation.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 two vitreotomes from two different procedures on different days did not cut at times, however, the aspiration was functioning.The products were replaced with another and the procedures were completed with no harm to the patients.No additional information is expected.

Manufacturer Narrative

Additional information provided.Two opened probes were received with tip protectors, in a bag, for the report of does not cut.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 three additional complaints associated with the lot for the reported issue.Sample #1 was visually inspected and found non-conforming with foreign matter in the inner diameter of the port and on the needle.The sample was then functionally tested for actuation, aspiration and cut.The sample was found conforming for aspiration and was non-conforming for actuation and cut.Sample #1 was then 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, the cutting edge, and several other locations along the inner cutter.After the probe was disassembled (bent needle with front shell removed), the probe was able to actuate.The initial actuation test was found non-conforming and a retest showed the cutter was able to actuate.Initial actuation test failures occur sometimes due to an interference causing the cutter to become stuck.Additional testing will remove the interference and the probe will then be able to function.Sample #2 was visually inspected and found conforming.The sample was then functionally tested for actuation, aspiration and cut.The sample was found conforming for aspiration and actuation and was non-conforming for cut.The probe was disassembled and the components inspected.Excessive 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, the cutting edge, and several other locations along the inner cutter.The complaint evaluation confirms that both returned probes had a cut issue.The evaluation also indicated that sample #1 had an actuation issue.The root cause for the cut and actuation non-conformances, as well as the observed foreign material on sample #1, was not able to be determined, however, the information in the file indicates that the probe functioned for some time during surgery.The evaluation of the returned sample confirms that the probe was used during surgery based on the visual presence of foreign matter (most likely surgical material) in the inner diameter of the port and on the needle as well as the gouge marks along the inner cutter, cutter edge, and several other locations along the inner cutter.The cause for the functional non-conformances for sample #1 does not point to a manufacturing related issue.The evaluation of sample # 2 showed excessive surgical use of the probe.The vitrectomy portion of the procedure is typically less than 20 minutes and it appears that sample #2 had experienced a use much greater than this typical timeframe.The excess usage of the probe will wear and damage the inner cutter such that the cutter function becomes poor, bent, or does not function at all.Sample #1 did not show signs of excessive use, however, the sample did show signs of surgical use, shown by the observed foreign matter in the port and on the needle.No action has been taken as the cause for the functional non-conformances for sample #1 was not able to be determined, and it appears that the observed non-conformances for sample #2 were due to excessive use of the probe by the user.Probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformances found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.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
• 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: 7635719
• MDR Text Key: 112429871
• Report Number: 2028159-2018-01321
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Hospital Service Technician
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Other Device ID Number: 380657511501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2012
• 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
• Patient Outcome(s): Other