MAUDE Adverse Event Report: STAAR SURGICAL AG IMPLANTABLE COLLAMER LENS (NON-TORIC); LENS, INTRAOCULAR, PHAKIC

Model Number MICL 13.2

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

Patient Problems Inflammation (1932); Pain (1994); Increased Sensitivity (2065); Visual Impairment (2138)

Event Date 11/03/2019

Event Type  Injury  

Event Description

Below is an email sent to staar surgical on 12/12/2019 about their medical device, after the implantation the non-toric icl.I have called staar surgical multiple times and not received a response about my condition or been able to get in touch with medical monitoring.Email with details below: on (b)(6), 2019 i had staar surgical icl's implanted in both eyes (non-toric) and am having major complications.I have cloudy vision in my left eye and my pupils are now 2 different sizes.I am very concerned as my surgeon has never seen this before.I had the surgery performed at (b)(6) with (b)(6).Have you seen this condition before and can it be treated? surgery was performed on (b)(6) 2019 and results were good immediately after.My last day taking post-op steroids was on (b)(6) 2019.Complications began 9 days post surgery on (b)(6) 2019 immediately after a 3 hour flight.After getting off the plane, i had a red ring around my left eye and my pupils were noticeably different sizes.Two days later on (b)(6) 2019, developed pain and light sensitivity in the left eye so i went to a dr.They said i had rebound inflammation and put me back on steroids.As things were seeming to get better, on (b)(6) i had an immediate onset of cloudiness in my left eyes.Half of my vision went gray and i could not see.To this day, i still have 2 different size pupils and my vision is consistently cloudy in my left eye.The cloudiness gets much worse when sunlight is hitting my eye directly, but some level of cloudiness is always there.I am very worried about the health of my eye and i hope that staar surgical can provide guidance.I've been to (b)(6) many times since complications began, and was told my eyes are healthy and they've never seen this before in any other pt.I am very worried about the condition of my eyes with your product, please advise next steps.I still have cloudiness in the left eye and 2 different sized pupils.Fda safety report id# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (NON-TORIC)
• Type of Device: LENS, INTRAOCULAR, PHAKIC
• Manufacturer (Section D): STAAR SURGICAL AG
• MDR Report Key: 9586135
• MDR Text Key: 175198099
• Report Number: MW5092202
• 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: 01/09/2020

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: MICL 13.2
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 28 YR
• Patient Weight: 64