MAUDE Adverse Event Report: OPHTEC BV ARTISAN; ARTISAN MYOPIA 6/8.5

Model Number 204001W

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cataract (1766); Glaucoma (1875)

Event Date 01/31/2021

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: ARTISAN
• Type of Device: ARTISAN MYOPIA 6/8.5
• Manufacturer (Section D): OPHTEC BV; schweitzerlaan 15; groningen, netherlands 9728 NR; NL 9728 NR
• Manufacturer Contact: fred wassenburg ; schweitzerlan 15; groningen, nr 9728 ; NL 9728
• MDR Report Key: 11495504
• MDR Text Key: 252966745
• Report Number: 8040449-2021-00001
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 204001W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR