MAUDE Adverse Event Report: OPHTEC BV VERISYSE MYOPIA

Model Number VRSM6

Device Problem Output Problem (3005)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Patient's iol was explanted, since it was causing the right eye's cell cone to diminish.Iol information: verisyse myopia iol 6/8.5, diopter -6.0, serial number (b)(4).

• Brand Name: VERISYSE MYOPIA
• Type of Device: VERISYSE
• Manufacturer (Section D): OPHTEC BV; schweltzerlaan 15; groningen, nr 9728 ; NL 9728
• Manufacturer Contact: fred wassenburg ; schweltzerlan 15; groningen, nr 9726 ; NL 9726
• MDR Report Key: 13052015
• MDR Text Key: 282735648
• Report Number: 8040449-2021-00004
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/15/2021

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 Model Number: VRSM6
• Device Catalogue Number: VRSM6US060N
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/21/2021
• 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): Required Intervention