FDA Adverse Event Injury Summary report: N

TECNIS

MDR report key: 2802903 · Received October 24, 2012

Report

Report Number: 2648035-2012-00323
Event Type: Injury
Date Received: October 24, 2012
Date of Event: September 20, 2012
Report Date: September 25, 2012
Manufacturer: ABBOTT MEDICAL OPTICS
Product Code: HQL
PMA / PMN Number: P990080
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). PRIOR TO RELEASE TO MARKET THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

Additional Manufacturer Narrative · 1

THE DEVICE WAS RETURNED TO THE MANUFACTURER. THE SAMPLE WAS INSPECTED IN MICROSCOPE AT 10X MAGNIFICATION. VISUAL INSPECTION REVEALED SURFACE RESIDUALS (FIBERS, PARTICLES AND STAINS) ON THE LENS SURFACE. SURFACE RESIDUALS ARE COMPATIBLE WITH HANDLING THE LENS NON-STERILE ENVIRONMENT. THEY WERE REMOVED AFTER THE LENS WAS CLEANED. THERE WERE NO UNACCEPTABLE COSMETIC CONDITIONS, CLOUDY OR OPACITY, OBSERVED IN THE RETURNED SAMPLE. THE COMPLAINT FOR CLOUDY LENS WAS NOT CONFIRMED.ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT ON (B)(6) 2012, DUE TO SYMPTOMS OF CLOUDY VISION AND TRAILING LIGHTS WHEN LOOKING AT OBJECTS. DURING THE EXPLANT THE SURGEON REMOVED THE INTRAOCULAR LENS (IOL) AND REPLACED WITH THE SAME MODEL (ZA9003). DATE OF ORIGINAL IMPLANT WAS REPORTED TO BE (B)(6) 2012. THE SPECIFIC IMPLANT DATE WAS NOT PROVIDED. NO ADDITIONAL INFORMATION OBTAINED AT THIS TIME. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL MDR WILL BE PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TECNIS	MONOFOCAL IOLS	HQL	ABBOTT MEDICAL OPTICS	ZA9003

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention