FDA Adverse Event Injury Summary report: N

REZOOM

MDR report key: 1939357 · Received December 28, 2010

Report

Report Number: 2648035-2010-00254
Event Type: Injury
Date Received: December 28, 2010
Date of Event: October 20, 2010
Report Date: December 1, 2010
Manufacturer: ABBOTT MEDICAL OPTICS
Product Code: MFK
PMA / PMN Number: P960028/SO11
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VE
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4) - THE MULTIFOCAL INTRAOCULAR LENS (IOL), LABELED 23.5 DIOPTERS, WAS RECEIVED CUT IN 2 PIECES ACROSS THE CENTER OF THE OPTIC PRECLUDING A COMPUTERIZED MEASUREMENT OF THE POWER. ONE PIECE OF THE LENS OPTIC WAS MEASURED FOR IOL CENTER THICKNESS (CT) ACCORDING TO MANUFACTURING SPECIFICATIONS. THE RESULTS SHOW THE CENTER THICKNESS OF THE RETURNED LENS MEASURES 0.043". THE SPECIFICATION FOR THIS MODEL LENS 23.5 DIOPTER IS .041" +/- .002" , THIS RESULT IS CONSISTENT WITH THE LABELED DIOPTER OF THE RETURNED IOL. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO DEVIATIONS DURING THE PROCESS. WHILE WE WERE UNABLE TO DEFINITIVELY DETERMINE THE CAUSE OF THIS ADVERSE EVENT OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. ALL INFORMATION AVAILABLE IS INCLUDED IN THIS REPORT.

Description of Event or Problem · 1

PHYSICIAN REPORTED A REFRACTIVE SURPRISE AFTER IMPLANTING THE REZOOM INTRAOCULAR LENS (IOL). PHYSICIAN IMPLANTED A 23.5 D LENS FOR AN ANTICIPATED POST-OPERATIVE REFRACTION TARGET OF -0.25 D. THE PATIENT'S REFRACTIVE OUTCOME WAS -3.75. LENS WAS EXPLANTED AND ANOTHER MULTIFOCAL LENS WITH THE SAME BIOMETRIC VALUES WAS IMPLANTED AND THE OUTCOME WAS -0.25.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	REZOOM	MULTIFOCAL INTRAOCULAR LENS	MFK	ABBOTT MEDICAL OPTICS	NXG1

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Required Intervention