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

Model Number LXT-JAPAN

Device Problems Break (1069); Suction Problem (2170); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2018

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 cutter's tip touched the infusion cannula while cutting the vitreous humor during a combined dislocated intraocular lens and retinal detachment procedure.It was initially reported the surgeon rubbed the cutter's tip against the light guide because he felt the aspiration was not good.An abnormal sound followed and the cutter's tip broke after 10-15 minutes.The procedure was completed after replacing the product with another one and the broken tip was removed from the patient's eye.There was no harm to the patient.No additional information is expected.

Manufacturer Narrative

One opened probe was received with a tip protector in a tray for the report of tip was broken, not retained in the eye, poor cutting, and abnormal noise.The tip of the probe was returned in a vial.A digital video disc (dvd) was also returned with the sample.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 no additional complaints associated with the lot for the reported issue.Three photos of the probe needle are attached to the parent file.These photos were reviewed by the manufacturing site.Two photos show the probe needle is broken at the port.The third photo shows the detached tip of the probe needle.A dvd of the surgical procedure was returned to the manufacturing site.The video confirms that the probe needle tip fell into the eye and was retrieved.The manufacturing site is unable to determine the total cutter actuation time or presence of the reported abnormal noise from the video the returned sample was visually inspected and was found non-conforming with the tip of the probe needle broken at the port.Functional test could not be performed due to the broken needle.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.The inner cutter is bent.Wear marks were observed at the bend area.Gouge marks were observed at the cutting edge and several other locations along the inner cutter.The complaint evaluation confirmed that the probe had a broken tip at the port.Functional testing could not be performed to determine whether or not the probe had a cut issue, however the damage seen to the tip during evaluation would have likely caused functional failure.The manufacturing site reviewed the surgical video and was able to confirm the tip fell into the eye and was retrieved.The manufacturing site is unable to determine the total cutter actuation time or presence of the reported abnormal noise from review of the video.The exact root cause for the broken tip cannot be determined from this evaluation.The most likely contributing factor to the broken tip at the port is excessive surgical use of the probe.The vitrectomy portion of the procedure is typically less than 20 minutes and it appears that the probe had experienced a use much greater than this typical timeframe.An internal investigation has been initiated to further evaluate the cause of probe tip breakage at the port.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints will continue to be reviewed and closely monitored at regular intervals for any significant adverse trends.No additional action is required at this time.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
• MDR Report Key: 7841788
• MDR Text Key: 119376688
• Report Number: 2028159-2018-01857
• 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: 11/30/2018

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: 09/10/2018
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 11/05/2018
• Supplement Dates FDA Received: 12/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK
• Patient Outcome(s): Other
• Patient Age: 61 YR