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

Model Number 204001W

Device Problem Output Problem (3005)

Patient Problem Corneal Decompensation (1790)

Event Date 04/14/2021

Event Type  Injury  

Manufacturer Narrative

Traceability review shows that the product was manufactured in accordance with specifications.No other events were reported for products from this lost.No additional clinical information is available.

Event Description

An artisan myopia piol was implanted on (b)(6) 2013.During a consult on (b)(6) 2020, it was observed that the cornea was decompensated in the left eye requiring a cataract surgery with iol explantation, combined with a cornea transplantation.Prior to the explantation, the endothelial cell count was 1000 cells/mm2.A corneal transplant was performed (dsaek).The lens was replaced with a regular cataract iol.

Manufacturer Narrative

The returned product was investigated.Product meets specifications.As stated in the initial report, review of product data (traceability review) shows that product was manufactured in accordance with specifications.No other events were reported regarding products from this lots.Additional information, including clinical information, was requested in order to analyze the case in detail.No further information was provided.No relevant information, including other previous ecc counts, biometry data of the eye, could be provided.Therefore the root cause could not be determined.

Event Description

An artisan myopia piol was implanted on (b)(6) 2013.During a consult on (b)(6) 2020 it was observed that the cornea was decompensated in the left eye requiring a cataract surgery with iol explantation combined with a cornea transplantation.Prior to the explantation, the endothelial cell count was 1000 cells/mm2.

• Brand Name: ARTISAN MYOPIA 6/8.5
• Type of Device: ARTISAN MYOPIA
• Manufacturer (Section D): OPHTEC BV; schweitzerlaan 15; nr 9728 ; NL 9728
• MDR Report Key: 11944799
• MDR Text Key: 254513458
• Report Number: 8040449-2021-00003
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: P030028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

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: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: 204001W
• Device Catalogue Number: 204001W26N
• Device Lot Number: 111072
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR