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

Model Number MICL12.1

Device Problem Insufficient Information (3190)

Patient Problems Cataract (1766); Foreign Body Sensation in Eye (1869); Itching Sensation (1943); Blurred Vision (2137); Excessive Tear Production (2235); Eye Pain (4467)

Event Date 06/03/2019

Event Type  malfunction  

Event Description

I had icl surgery on (b)(6) 2009.In 2011, i started to have issues with my vision.I had to start wearing eye glasses to drive and then ended up with -1.25 vision to this date.In (b)(6) 2019 i started to have an itching/poking feeling in my right eye.My eye continued to water and itch as if something was poking me.I visited several eye doctors, including my surgeon who had done my icl surgery.It feels/felt as if something was wrong with my icl.The pain is behind my eye.The surgeon stated that i have a small cataract now on my eye and that is causing my blurry vision and the issue.I am having blurry vision, but i am still witnessing the watery/itching sensation.The surgeon dr.Liu advised i need to get my icl implant taken out and input a cataract lenses.I stated that i do not feel this is right.Something is not right with the current ilc lenses inside my eye.I have since dealt with this continued effect for the past two years.Eye doctors cannot figure it out.It is not my cataract causing this sensation.It's almost like my icl is trying to poke out of my eye or come out.I am finally getting a second opinion this next week with another eye surgeon to check my icl.To see if that is in fact the issue, as my right eye is still itching, watery.I can't put a contact in my right eye as it is too bothersome.I want to report this as i feel after this many years perhaps the lenses has gone bad or it needs replaced after a certain time.When i did icl back in 2009 it was new and just becoming a thing.Perhaps the icl's back then are not as up to date as what they have created now.Staar surgical icl implants.Implant icl: micl12.1 right eye.Diopter.-10.0/ optic diameter 4.9-5.8mm overall diameter: 12.1m.Sn: (b)(4) left eye: diopter.-10.5/ optic diameter 4.9- 5.8mm overall diameter: 12.2m sn: (b)(4).Fda safety report id # (b)(4).

• Brand Name: STAAR SURGICAL ICL IMPLANT
• Type of Device: LENS, INTRAOCULAR, PHAKIC
• Manufacturer (Section D): STAAR SURGICAL COMPANY
• MDR Report Key: 11435324
• MDR Text Key: 238871793
• Report Number: MW5099834
• Device Sequence Number: 2
• Product Code: MTA
• Combination Product (y/n): Y
• 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: 03/04/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MICL12.1
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 61