FDA Adverse Event Injury Summary report: N

ARTISAN

MDR report key: 11495504 · Received March 16, 2021

Report

Report Number: 8040449-2021-00001
Event Type: Injury
Date Received: March 16, 2021
Date of Event: January 31, 2021
Report Date: March 12, 2021
Manufacturer: OPHTEC BV
Product Code: HQL
PMA / PMN Number: P030028
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION: THE OCCURENCE OF CATARACT IS TYPICALLY AGE RELATED AND IT IS SHOWN TO OCCUR EARLIER FOR MYOPIC PATIENTS. GLAUCOMA CAN NEGATIVELY AFFECT THE ENDOTHELIAL CELL COUNTS (ECC) AND THEREFORE CAN BE A CONTRIBUTING FACTOR FOR THE CAUSE OF ECC LOSS. THE EXACT CAUSE FOR THE ECC LOSS CANNOT BE DETERMINED DUE TO A LACK OF CLINICAL DATA.

Description of Event or Problem · 1

SHORT DESCRIPTION: EXPLANTATION OF AN ARTISAN (ARTISAN MYOPIA 6/8.5) PHAKIC INTRAOCULAR LENS (PIOL) DUE TO CATARACTS, GLAUCOMA, AND ENDOTHELIAL CELL LOSS. DETAILED DESCRIPTION: (B)(6) YEAR OLD PATIENT WAS PREVIOUSLY IMPLANTED WITH AN ARTISAN PHAKIC INTRAOCULAR LENS (PIOL), IN THE RIGHT EYE, IN 2001. PATIENT DEVELOPED CATARACTS, GLAUCOMA, AND LOW ENDOTHELIAL CELL COUNTS (750 CELL/MM3). ON (B)(6) 2021, THE PATIENT'S ARTISAN IOL WAS EXPLANTED AT (B)(6). A CATARACTS IOL, MANUFACTURED BY ALCON, WAS IMPLANTED IN THE POSTERIOR CHAMBER OF THE PATIENT'S RIGHT EYE. PRODUCT DESCRIPTION: THE SERIAL NUMBER AND LOT NUMBER OF THE PHAKIC INTRAOCULAR LENS (PIOL) COULD NOT BE PROVIDED. INFORMATION REGARDING THE MODEL/CATALOGUE OF THE PIOL COULD NOT BE PROVIDED. THE PRODUCT WAS RETURNED AND MET 204001W (ARTISAN MYOPIA 6/8.5) SPECIFICATIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
394428	ARTISAN	ARTISAN MYOPIA 6/8.5	HQL	OPHTEC BV	204001W

Patients

Seq	Age	Sex	Outcome	Treatment
1	49 YR		Required Intervention