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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vitreous Floaters (1866); Visual Impairment (2138)

Event Date 09/05/2019

Event Type  Injury  

Event Description

Got visian icl plastic lens implants in both eyes.In left eye over a year later i had symptoms of foggy vision new floaters and today my vision is almost gone.There's a huge blob of water blocking my sight.When i move my eye i can see the water move.Fda safety report id# (b)(4).

• Brand Name: VISIAN ICL
• Type of Device: LENS, INTRAOCULAR, PHAKIC
• Manufacturer (Section D): STAAR SURGICAL COMPANY
• MDR Report Key: 8982553
• MDR Text Key: 157730581
• Report Number: MW5089673
• 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: Patient
• Type of Report: Initial
• Report Date: 09/05/2019

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 28 YR
• Patient Weight: 69