FDA Adverse Event Injury Summary report: N

CENTURION VISION SYSTEM

MDR report key: 3760886 · Received April 9, 2014

Report

Report Number: 2028159-2014-00575
Event Type: Injury
Date Received: April 9, 2014
Date of Event: March 12, 2014
Report Date: March 12, 2014
Manufacturer: ALCON - IRVINE TECHNOLOGY CENTER
Product Code: HQC
PMA / PMN Number: K121555
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

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).

Description of Event or Problem · 1

A NURSE REPORTED, A PT EXPERIENCED A THERMAL BURN DURING A CATARACT EXTRACTION PROCEDURE. SUTURES WERE USED TO CLOSE THE WOUND. ADDITIONAL INFORMATION WAS RECEIVED VIA A COMPLETED QUESTIONNAIRE INDICATING THAT THE BURN WAS NOTED VERY EARLY IN THE CASE. A FEMTO LASER PROCEDURE WAS PERFORMED FOR LENS SOFTENING INITIALLY. DURING PHACOEMULSIFICATION, WHEN PERFORMING ASPIRATION TO CLEAR THE VISCOATE OVERLYING THE NUCLEUS, A WHITE CLOUD FORMED AT THE TIP OF THE PROBE. IT WASN'T CLEAR IF THIS WAS EMULSIFIED LENS CORTEX OR SOME UNUSUAL VISCOELASTIC REACTION. WHEN THE SURGEON DEPRESSED THE FOOTPEDAL, NO ASPIRATION WAS RECEIVED. ASPIRATION WAS INCREASED AND GOOD ASPIRATION WAS NOTED. AT THAT POINT, THE BURN WAS NOTED. THE SURGEON STATED AFTER CONSULTING WITH THE REPS AFTER THE CASE, THEY REPORTED THE SETTINGS WERE TURNED DOWN A BIT TOO LOW. THE PROCEDURE WAS COMPLETED. THE PT IS STILL UNDER TREATMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
212916	CENTURION VISION SYSTEM	PHACOFRAGMENTATION SYSTEM	HQC	ALCON - IRVINE TECHNOLOGY CENTER	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR		Required Intervention	CENTURION OZIL HP