MAUDE Adverse Event Report: STAAR SURGICAL COMPANY VISIAN IMPLANTABLE CONTACT LENS; LENS, INTRAOCULAR, PHAKIC

Device Problems Unexpected Therapeutic Results (1631); Material Twisted/Bent (2981)

Patient Problem Cataract (1766)

Event Date 09/16/2022

Event Type  Injury  

Event Description

In (b)(6) 2020, i received visian icl surgery in both my eyes.Two years later at 30 years old, i am needing them removed and cataract surgery to treat cataracts in both my eyes.My surgeon said that the cataracts were caused by a buildup of fluid between the icl lens and my natural lens due to a "kink" in the lens.I still had not paid off my icl lenses at this time, it was a devastating blow.I have not had the surgery yet but it's getting hard to see.Fda safety report id# (b)(4).

• Brand Name: VISIAN IMPLANTABLE CONTACT LENS
• Type of Device: LENS, INTRAOCULAR, PHAKIC
• Manufacturer (Section D): STAAR SURGICAL COMPANY
• MDR Report Key: 15770939
• MDR Text Key: 303580335
• Report Number: MW5113203
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/07/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White