MAUDE Adverse Event Report: ALCON RESEARCH, LLC ACRYSOF IQ IOL (INTRAOCULAR LENS)

Model Number SN60WF

Patient Problems Visual Impairment (2138); Ptosis (2620)

Event Date 09/23/2015

Event Type  Injury  

Event Description

In 2015, i had an intraocular lens implanted during cataract surgery.This was my second lens implant after having my right eye done the year before in (b)(6).Both are the acrysof iq lenses.After taking off the eye patch the following day, my vision was perfect and i could see clearly again, even at great distances, but the doctor did not implant a multifocal lens as i asked.When i asked, he stated that this lens was what he chose and would work just fine, but i would need reading glasses from then on to read.But over the following weeks to months, i started having other problems besides not being able to read without glasses and having no depth perception.First was that my vision had again become cloudy or hazy with just a few weeks.He determined it was posterior capsular opacification, a supposedly common occurrence.A yag laser treatment was used to clear the back of the capsule the lens sits in.My vison returned to normal with 20/20 vision in that eye, but it did not end the problems.At just after the 3 months point, i started seeing double and over time my eyelids started to droop (ptosis) to the point where i had to lift them with my fingers to read.I was finally sent to see an ophthalmologist who specializes in ted (thyroid eye disease) and diplopia.He stated that both my eyes tracked equally, but felt i had issues with ptosis.He sent me to a plastic surgeon who then scheduled a performed a blepharoplasty in 2022, but my eyelids continued to droop again over time.It was suggested that i had dry eyes and needed moisturizing drops, prisms in my eyeglasses, and a host of other things that did not work or correct the problem.I started seeing a new ophthalmologist this year and he finally took my double vision seriously after complaining that i now am seeing triple at times, the more the day goes on, the worse my vision becomes, yet my vision test comes back as having almost 20/20 vision.He sent me back to the first ted/diplopia doctor i saw, and he determined that i did not have ted (thyroid eye disease) but he felt the problem was either the implanted lens, the capsule it was implanted in or my cornea.He also felt my vision issue was monocular diplopia in my left eye (i only have vision in my left eye, my right eye had malpractice damage when i was younger, so i don't know how he assumed it's monocular diplopia as no other test were done to rule this out.He then stated at this time there is no remedy for the issues i am having, and surgery at this point is impossible as would only damage or destroy the capsule, so there is no replacing it.I have since found out that this is a common occurrence in lenses made by alcon.I contacted the american academy of ophthalmologist for answers, options and opinions.Many ophthalmologists at this point have reported removing and replacing lenses damage during the safe three-month period because of the material the lens is made of, stating it is too soft and damaged easily during implantation, or by the devices or the surgeon used.I have discovered several are no longer using this lens or others made by alcon.Besides this fact some have reported cloudiness.I have been followed for many years until recently when i was diagnosed with wet amd (age-related macular degeneration) in (b)(6) of 2019 before the pandemic, being that i am a ted (thyroid eye disease).At this time my visits are now every two months for injections to treat the disease.It has never been reported by any ophthalmologist until now that they've see damage to the lens while looking at my eyes.My right lens is fine as far as i know.Lens is defective with cloudiness and possible scratches.Lens cannot be explanted.

• Brand Name: ACRYSOF IQ IOL (INTRAOCULAR LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 17691345
• MDR Text Key: 322924984
• Report Number: MW5145199
• Device Sequence Number: 1
• Product Code: HQL
• 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: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: SN60WF
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: 50000U CRESTOR LANTUS (FOR PUMP FAILURE ONLY) MIRENA IUD.; ALBUTEROL INHALER.; ALEVE.; BAQSIMI.; CHLORTHALIDONE.; CRESTOR.; E[INVALID]VAGINAL RING.; HUMALOG U100.; LANTUS (FOR PUMP FAILURE ONLY).; LEVOTHYROXIN.; LIOTHYRONINE.; LOSARTAN.; MINOCYCLINE.; MIRENA IUD (INTRAUTERINE DEVICE).; OMNIPOD5 INSULIN PUMP AND RECEIVER DEXCOM G6 CGM (CONTINUOUS GLUCOSE MONITOR) WITH APP. ; OZEMPIC.; PANTOPRAZOLE.; VITAMIN D 50000U.
• Patient Outcome(s): Disability
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White