FDA Adverse Event Injury Summary report: N

TECNIS

MDR report key: 2832435 · Received November 14, 2012

Report

Report Number: 2648035-2012-00355
Event Type: Injury
Date Received: November 14, 2012
Date of Event: October 10, 2012
Report Date: October 18, 2012
Manufacturer: ABBOTT MEDICAL OPTICS
Product Code: MFK
PMA / PMN Number: P990080
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4) - REMOVAL AND REPLACEMENT OF INTRAOCULAR LENS.THE RETURNED LENS WAS INSPECTED AT 10X MICROSCOPE MAGNIFICATION WHICH ILLUSTRATED A LARGE CUT IN THE OPTIC AND BOTH HAPTICS WERE DETACHED FROM THE LENS. THIS CONDITION MAY BE A CONSEQUENCE OF THE LENS EXPLANT PROCESS. IN ADDITION, LENS HAS SURFACE RESIDUALS ADHERED TO BOTH SIDES OF THE OPTIC BODY, WHICH ARE COMPATIBLE WITH HANDLING THE LENS AFTER IT WAS EXPLANTED. THE LENS WAS INSPECTED FOR OPTICAL PROPERTIES AND SHOWED THAT THE LENS DIOPTER WAS WITHIN SPECIFICATION.PRIOR TO RELEASE TO MARKET THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS.ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL AND EXCHANGE OF AN INTRAOCULAR LENS (IOL) DUE TO A DIFFERENCE IN DIOPTER SIZE. THE DIFFERENCE IN THE DIOPTER WAS STATED TO BE CAUSED BY A PREVIOUS CORNEAL TRANSPLANT. THE ORIGINAL LENS, A ZA900 10.5D, WAS IMPLANTED (B)(6), 2012. THIS INTRAOCULAR LENS (IOL) WAS EXPLANTED AND REPLACED WITH AN AR40M -6.0D INTRAOCULAR LENS (IOL). IT WAS REPORTED THAT THE PHYSICIAN RE-OPENED THE PREVIOUS INCISION DURING THE PROCEDURE. PATIENT WAS STATED TO BE DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR		Required Intervention