TECNIS

MDR report key: 2801887 · Received October 23, 2012

Report

Report Number: 2648035-2012-00331
Event Type: Injury
Date Received: October 23, 2012
Date of Event: August 30, 2012
Report Date: October 9, 2012
Manufacturer: ABBOTT MEDICAL OPTICS
Product Code: HQL
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). ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

Additional Manufacturer Narrative · 1

THE EXPLANTED INTRAOCULAR LENS (IOL) WAS RETURNED TO OUR MANUFACTURING FACILITY FOR EVALUATION. THE LENS BELONGS TO THE MANUFACTURING PRODUCTION ORDER OF A SIZE 18.5 DIOPTER, MODEL ZA9003. THE RETURNED LENS WAS INSPECTED AT 10X MICROSCOPE MAGNIFICATION AND FOUND TO HAVE SURFACE RESIDUALS ADHERED TO BOTH SIDES OF THE OPTIC BODY COMPATIBLE WITH HANDLING, DURING THE EXPLANT OF THE LENS. THE MANUFACTURING CERTIFIED OPERATOR CLEANED THE LENS TO REMOVE THE CONTAMINATION AND THEN VISUALLY INSPECTED THE LENS WITH NO OTHER COSMETIC DEFECTS FOUND. THE MANUFACTURING CERTIFIED OPERATOR INSPECTED THE LENS FOR OPTICAL PROPERTIES AND THE RESULTS SHOWED THAT THE LENS DIOPTER CORRESPONDED TO A SIZE 18.5 DIOPTER LENS. AN IMPROPER IOL (LENS) POWER WAS NOT VERIFIED IN THE RETURNED LENS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

Description of Event or Problem · 1

WE RECEIVED A REPORT FROM A SURGERY CENTER THAT A MALE PATIENT HAD AN INTRAOCULAR LENS EXPLANTED AFTER HE EXPERIENCED POST-OPERATIVE DYSPHOTOTOPSIA. NO PATIENT INJURY WAS REPORTED.

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	66 YR		Required Intervention