FDA Adverse Event Malfunction Summary report: N

C-FLEX

MDR report key: 3674417 · Received February 24, 2014

Report

Report Number: 9611165-2014-00038
Event Type: Malfunction
Date Received: February 24, 2014
Report Date: January 20, 2014
Manufacturer: RAYNER INTRAOCULAR LENSES LTD.
Product Code: HQL
PMA / PMN Number: P060011
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER INTRAOCULAR LENSES LTD. REMEDIAL, CORRECTIVE AND PREVENTIVE ACTION WAS TAKEN BY THE HEALTHCARE FACILITY IN THE ORIGINAL PLANNED SURGERY SESSION. C-FLEX 570C IOL SUBJECT TO THIS REPORT WAS EXPLANTED AND EXCHANGED FOR A BACK-UP LENS WITHOUT FURTHER COMPLICATION. THE HEALTHCARE FACILITY HAS CONFIRMED THAT THE PATIENT WAS NOT INJURED AS A RESULT OF THIS EVENT. THE EXPLANTED C-FLEX 570C IOL WAS DISCARDED BY THE HEALTHCARE FACILITY. NO DEVICE INSPECTION/ANALYSIS COULD BE PERFORMED BY RAYNER INTRAOCULAR LENSES LTD. WITHIN THE INITIAL NOTIFICATION OF THIS CASE. THE RAYNER (B)(4) SALES MANAGER WAS ADVISED BY THE HEALTHCARE PROFESSIONAL THAT THE ROOT CAUSE OF THE HAPTIC GETTING CAUGHT DURING IMPLANTATION MAY BE USER ERROR. IN ORDER TO PREVENT THE RECURRENCE OF THE EVENT, ADDITIONAL LENS LOADING TRAINING WILL BE PROVIDED TO THE HEALTHCARE PROFESSIONAL BY THE RAYNER (B)(4) SALES MANAGER.

Description of Event or Problem · 1

RAYNER INTRAOCULAR LENSES LTD. RECEIVED NOTIFICATION FROM A (B)(4) HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A C-FLEX 570C INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY STATES THAT THE LENS HAPTIC GOT CAUGHT DURING IMPLANTATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
111839	C-FLEX	HQL - INTRAOCULAR LENSES	HQL	RAYNER INTRAOCULAR LENSES LTD.	570C	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1