FDA Adverse Event Injury Summary report: N

TECNIS

MDR report key: 2821766 · Received November 6, 2012

Report

Report Number: 2648035-2012-00350
Event Type: Injury
Date Received: November 6, 2012
Date of Event: October 8, 2012
Report Date: October 18, 2012
Manufacturer: ABBOTT MEDICAL OPTICS
Product Code: HQL
PMA / PMN Number: P990080
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). PRIOR TO RELEASE TO MARKET THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS.ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

Additional Manufacturer Narrative · 1

THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. THE IOL WAS INSPECTED AT 10X MICROSCOPE MAGNIFICATION. VISUAL INSPECTION REVEALED SURFACE RESIDUALS (FIBERS, PARTICLES, AND STAINS) AND DRY LUBRICANT SOLUTION ON THE LENS SURFACE. SURFACE RESIDUALS ARE COMPATIBLE WITH HANDLING THE LENS OUT OF A STERILE ENVIRONMENT. ALSO, ONE OF TIP LOOP (HAPTICS) WAS BROKEN. CURRENT MANUFACTURING CONTROLS: AT THE FINAL INSPECTION PROCESS LENSES ARE 100% CLEANED AND INSPECTED AT 10X MICROSCOPE MAGNIFICATION FOR COSMETIC DEFECTS INCLUDING HAPTIC DEFECTS AND SURFACES RESIDUALS. THEREFORE, THE SAMPLE'S CONDITION DOES NOT SUGGEST BEING A MANUFACTURING RELATED ISSUE AND MAY BE A CONSEQUENCE OF THE EXPLANT PROCESS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURE HAS BEEN SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL OF AN INTRAOCULAR LENS (IOL) DUE TO ZONULYSIS. IT WAS REPORTED THAT THE LENS WAS INSERTED THEN REMOVED IN THE SAME PROCEDURE. IT WAS STATED THAT THE SURGICAL SITE WAS ENLARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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			Required Intervention