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

Catalog Number 8065751761

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Burn, Thermal (2530); Intraocular Pressure Decreased (4468); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/12/2021

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.(b)(4).

Event Description

A nurse reported that during a surgery, a patient developed thermal injury in the left eye.When the surgeon started to sculpt with hand piece he received a tip wound that turned white at the incision.The patient had iris prolapse prior to starting the case.The surgeon settings for torsional in sculpt was 5/60, vacuum in sculpt was at 20/125 and aspiration rate fixed 25 using 2.4 incisions.The surgeon sutured tight at the temporal left eye.The patient had no complications with the right eye.

Manufacturer Narrative

Corrected information is provided in b.3.Additional information is provided in a,1, a.2, a.3, a.4, b.2, b.3, b.5, b.6, b.7, e.4 and h.10.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received clarified that at the beginning phacoemulsification mode of the cataract the surgeon began to see white plume as soon as the pedal was depressed.The surgeon removed the phacoemulsification tip from eye.The hand piece flushed and the procedure was completed.The cataract was removed and a lens placed in the bag and the main wound where the burn was located was closed with suture and tissue sealant glue.No occlusion tone heard from the system.The burn was located in the cornea, superonasally.The case was already complicated by some element of malignant glaucoma/aqueous misdirection and iris prolapse before the wound burn.The anterior chamber was shallowed before the burn occurred.Post operatively, she has been stable and her anterior chamber has been deep.The patient is noted to have astigmatism and they are slowly removing sutures.The surgeon suspected that there might have been a smaller piece of material which was in the lumen of the handpiece that may have positioned itself in a way that allowed it not to obstruct until further vacuum was placed on the system.It was obvious that the occlusion occurred as soon as the pedal was depressed as that was when the wound turned white.The sleeve was in proper position.

Manufacturer Narrative

Corrected information is provided in h.6.Additional information is provided in b.5.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received clarified that the patient was healing slowly and had a rebound in inflammation when they dropped her steroids but she was improving.They are taking out stitches slowly.

Event Description

Additional information received indicated that the patient still had some limited vision about 20/100 and the best they corrected her to was about 20/70.The surgeon suspected that some of the scar from the burn goes down into her visual axis.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information is provided in h.6 and h.10.The phacoemulsification handpiece was not returned for evaluation.The phacoemulsification handpiece manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported event could not be confirmed.The root cause cannot be determined conclusively.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: 11271707
• MDR Text Key: 230012895
• Report Number: 2028159-2021-00121
• 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,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751761
• Device Lot Number: 13MN6D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR