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

Catalog Number 8065750469

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

The phacoemulsification (phaco) handpiece was received and a visual assessment of the returned phaco handpiece found no visual nonconformities.The returned phaco handpiece was connected to a calibrated infiniti vision system.The phaco handpiece tuned successfully and completed a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.The phaco handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements, which found the phaco 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.Corneal burn is an issue that is occasionally reported with cataract surgery.According to the pennsylvania patient safety advisory abstract: preventing corneal burns during phacoemulsification, march 2010, vol.7, no.1: 23-25, most corneal burns can be traced to issues related to surgical technique and not to malfunctioning equipment.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 9772607
• MDR Text Key: 181532770
• Report Number: 2028159-2020-00169
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K121555
• 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: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065750469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/29/2020
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION; HEALON V; PHACO TIP
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR