MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE; UNIT, PHACOFRAGMENTATION

Catalog Number 8065752914

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Corneal Edema (1791); Irritation (1941); Eye Burn (2523)

Event Date 01/29/2020

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 surgeon reported a patient experienced a corneal burn during a cataract procedure.The surgeon filled the anterior chamber with viscoelastic, started sculpting and immediately it appeared dusty, smoky and milky at the tip.Phacoemulsification seemed ineffective.The surgeon stopped and checked to make sure everything was okay, then resumed sculpting.Again, the surgeon noticed that phacoemulsification seemed ineffective.The surgeon stopped and observed a corneal incision contracture.The surgeon removed the phacoemulsification handpiece from the eye a third time to check to make sure everything was okay.He noted that there was no signal from the device.The surgeon flushed out the healon v with regular healon, continued phacoemulsification with the same handpiece and was able to proceed as expected.The cataract was removed and an intraocular lens was implanted.There was a classic fish mouth appearance at the incision site which required sutures.The surgeon indicated that the patient may develop astigmatism post-operatively and will need to be monitored.The surgeon indicated that his theory is the event had to do with the viscoelastic however, two handpieces will be returned for evaluation.It is unknown which handpiece was used during the event.Additional information was received indicating that the patient returned on (b)(6) 2020 for postoperative evaluation.The patient presented with corneal edema, edema around the incision area.The patient reported irritation from the sutures.

Manufacturer Narrative

Additional information has been provided in d.10, h.3, h.6 and h.10.The phacoemulsification (phaco) handpiece was received and a visual assessment of the returned sample found no visual nonconformities.The phaco handpiece was connected to a calibrated resistance breakout box, where the output and input impedances were found to be within specification.A flow rate test was performed on the irrigation and aspiration lines of the phaco handpiece, which found the phaco handpiece to meet product specifications.The returned phaco handpiece was connected to a calibrated system.The handpiece tuned successfully and completed a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.The handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements, which found the handpiece to meet product specifications.The phaco handpiece manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The phaco handpiece was found to meet specifications; therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 9772609
• MDR Text Key: 181533144
• Report Number: 2028159-2020-00170
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K161794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065752914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION.; HEALON.; PHACO TIP.
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR