FDA Adverse Event Injury Summary report: N

TECNIS

MDR report key: 2233421 · Received September 2, 2011

Report

Report Number: 2648035-2011-00196
Event Type: Injury
Date Received: September 2, 2011
Date of Event: August 4, 2011
Report Date: August 5, 2011
Manufacturer: ABBOTT MEDICAL OPTICS
Product Code: HQL
PMA / PMN Number: P99080
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MT, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE INTRAOCULAR LENS WAS RECEIVED AND SENT TO THE MANUFACTURING SITE FOR ANALYSIS. RESULTS ARE PENDING. PRIOR TO RELEASE THE LENS MET ALL MANUFACTURING SPECIFICATIONS. OUR INVESTIGATION REVEALED THE INITIAL IMPLANT OF 18.0 DIOPTER WAS REPLACED WITH A 22.0 DIOPTER LENS OF THE SAME MODEL. THIS SUGGESTS THE IOL WAS NOT THE CAUSE OF THIS EVENT. 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 RETURNED IOL WAS MEASURED FOR DIOPTER AND WAS CORRECT AS LABELED, 18.0 D. THE IOL MET ALL SPECIFICATIONS FOR OPTICAL PROPERTIES. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. 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 INTRAOCULAR LENS WAS EXPLANTED (B)(6) AFTER IMPLANT DUE TO A REFRACTIVE SURPRISE. NO INJURY OR ADVERSE EFFECTS TO THE PATIENT.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR		Required Intervention