MAUDE Adverse Event Report: OPHTEC BV ARTISAN; ARTISAN MYOPIA

Device Problem Insufficient Information (3190)

Patient Problem Corneal Decompensation (1790)

Event Date 12/09/2020

Event Type  Injury  

Manufacturer Narrative

A minimum cell count of 1500 cells/mm2 is often an indication of piol explantation by experts.The surgeon explanted the artisan iol in this case as a precaution.Additional clinical information was not provided.Potential cause of endothelial cell count (ecc) loss therefore cannot be determined.

Event Description

Short description: a (b)(6) year old patient has been hospitalized for explantation of an implant in the anterior chamber od (right eye), clipped on the anterior side of the iris.The patient also underwent phacoemulsification and a new implant was placed in the posterior chamber of the right eye.Background: the user reported the artisan lens was implanted in 2002.The lens was implanted to treat the patients myopia.It was reported that the implantation of the artisan lens was performed in (b)(6).Name of the hospital and surgeon were not provided.Detailed description: the user reported that an artisan lens (model not provided) was explanted due to endothelial cell loss 19 years after implantation.It was reported that the artisan lens explantation was performed at (b)(6) on (b)(6) 2020.The endothelial cell count (ecc) count of the (b)(6) year old patient was 1800 cells/mm2 two months prior to explantation.The surgeon explanted the lens as a precaution.Artisan lens specifications: the user was unable to report the serial number, lot number, and/or model.No further specification was provided.

• Brand Name: ARTISAN
• Type of Device: ARTISAN MYOPIA
• 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: 11830548
• MDR Text Key: 250825477
• Report Number: 8040449-2021-00002
• 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,user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR