FDA Adverse Event Injury Summary report: N

SUPERFLEX ASPHERIC

MDR report key: 3953345 · Received July 18, 2014

Report

Report Number: 3003563511-2014-00062
Event Type: Injury
Date Received: July 18, 2014
Date of Event: March 3, 2014
Report Date: June 12, 2014
Manufacturer: RAYNER INTRAOCULAR LENSES LIMITED
Product Code: HQL
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: IN
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

RAYNER'S REVIEW OF PRODUCTION RECORDS FOR THE SUPERFLEX ASPHERIC 920H IOL BATCH 093E51185 SHOWED THAT ALL MANUFACTURING AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. THERE ARE NO ISSUES ASSOCIATED WITH THE MANUFACTURE OF THESE BATCHES AND ALL STERILISATION ACTIVITIES WERE CARRIED OUT SUCCESSFULLY WITHOUT COMPLICATION. ALL DEVICES RELEASED FOR DISTRIBUTION FROM THE SUPERFLEX ASPHERIC 920H IOL BATCH 093E51185 WERE WITHIN TOLERANCE, MET SPECIFICATION CRITERIA AND WERE WITHOUT DEFECTS. THE BIOBURDEN AND ENDOTOXIN RESULTS FOR THE SUPERFLEX ASPHERIC 920H IOL BATCH 093E51185 WERE REVIEWED. THE BIOBURDEN RESULTS FOR THESE DEVICES WERE BELOW TARGET LEVEL AND THE ENDOTOXIN RESULTS WERE AT THE 0.5EU/DEVICE.

Description of Event or Problem · 1

RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM ITS (B)(4) DISTRIBUTOR OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A SUPERFLEX ASPHERIC 920H INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED STATES THAT ENDOPHTHALMITIS WAS OBSERVED IN THE POST-OPERATIVE PERIOD. FOR FURTHER INFO PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR 9611165-2014-00062.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
423361	SUPERFLEX ASPHERIC	HQL - INTRAOCULAR LENS	HQL	RAYNER INTRAOCULAR LENSES LIMITED	920H	093E51185

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR		Required Intervention	POST-OP GATIFLOXACILLIN WITH DEXAMETHASONE\| VINCOMYCIN\| AMIKACIN