FDA Adverse Event Death Summary report: N

TECNIS ZA9003 IOL

MDR report key: 1654128 · Received March 30, 2010

Report

Report Number
1654128
Event Type
Death
Date Received
March 30, 2010
Date of Event
March 13, 2010
Report Date
March 30, 2010
Manufacturer
AMO
Product Code
HQL
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
MN, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

PATIENT RECEIVED RIGHT LENS IMPLANT EARLY THIS YEAR. NO PROBLEMS WITH SURGERY OR FOLLOW-UP CARE. APPROXIMATELY TWO MONTHS LATER, THE PATIENT WAS DIAGNOSED WITH PNEUMONIA AND GIVEN ANTIBIOTICS AT A CLINIC. WITHIN 6 HOURS OF TAKING MEDS, FACE BEGAN TO SWELL. CAME TO OUR ER 5 DAYS LATER, AND WAS DIAGNOSED WITH NECROTIZING FASCIITIS. WAS TAKEN TO THE OR FOUR CONSECUTIVE DAYS FOR DEBRIDEMENT OF PARAPHARYNGEAL SPACE, RIGHT LIP, FACE AND PAROTID AREA. CULTURES GREW MRSA. SEPTIC SHOCK - TREATMENT WITH VANO, ZOSYN, CLINDAMYCIN AND FLUCONAZOLE. PATIENT DIED ON THE FOURTH DAY.====================== HEALTH PROFESSIONAL'S IMPRESSION======================MD UNSURE IF THIS EVENT HAD ANYTHING TO DO WITH THE CORNEAL LENS IMPLANT FROM 2 MONTHS PRIOR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TECNIS ZA9003 IOL INTRAOCULAR LENS IMPLANT HQL AMO ZA9003 *

Patients

Seq Age Sex Outcome Treatment
1 63 YR Death CARDIAC DRUGS