FDA Adverse Event Injury Summary report: N

TECNIS MULTIFOCAL

MDR report key: 2250802 · Received September 16, 2011

Report

Report Number: 9614546-2011-00081
Event Type: Injury
Date Received: September 16, 2011
Date of Event: August 16, 2011
Report Date: August 17, 2011
Manufacturer: ABBOTT MEDICAL OPTICS
Product Code: MFK
PMA / PMN Number: P980040
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF THE MANUFACTURER'S IMPLANT DATABASE CONFIRMS THE ORIGINAL IMPLANT WAS REMOVED AND REPLACED WITH A MONOFOCAL LENS. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

THE LENS WAS RECEIVED CUT IN TWO PIECES ACROSS THE OPTIC PRECLUDING MEASUREMENT OF THE DIOPTER. VISUAL INSPECTION OF THE OPTIC PARTS SHOWED NO DEVIATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND MET SPECIFICATIONS. HALOS AND GLARE ARE A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF ALL MULTIFOCAL LENS IMPLANTS. OUR INVESTIGATION REVEALED NO PRODUCT DEFICIENCIES. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THE MULTIFOCAL INTRAOCULAR LENS WAS EXPLANTED DUE TO THE PATIENT'S INABILITY TO ADAPT TO THE POWER CONTRAST. PATIENT COMPLAINED OF HALOS AND GLARE AT NIGHT AND HAD ISSUES WITH DEPTH PERCEPTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TECNIS MULTIFOCAL	MULTIFOCAL INTRAOCULAR LENS	MFK	ABBOTT MEDICAL OPTICS	ZMB00

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention