MAUDE Adverse Event Report: STAAR SURGICAL COMPANY STAAR EVO+ VISIAN ICL/ IOL INTRAOCULAR LENSE; LENS, INTRAOCULAR, PHAKIC

Model Number VISIAN EVO+

Device Problem Pressure Problem (3012)

Patient Problems Glaucoma (1875); Loss of Vision (2139); No Code Available (3191)

Event Date 02/16/2018

Event Type  Injury  

Event Description

Install icl led to pressure issues, blown iris, ongoing glaucoma and loss of vision.Lens was implanted and after a few weeks experienced pressure issues, iris permanently fixed a dilated and ongoing glaucoma issues.

• Brand Name: STAAR EVO+ VISIAN ICL/ IOL INTRAOCULAR LENSE
• Type of Device: LENS, INTRAOCULAR, PHAKIC
• Manufacturer (Section D): STAAR SURGICAL COMPANY
• MDR Report Key: 10032334
• MDR Text Key: 190462794
• Report Number: MW5094406
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2020

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?: Yes
• Device Operator: No Information
• Device Model Number: VISIAN EVO+
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/06/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 48 YR
• Patient Weight: 73