MAUDE Adverse Event Report: TORIC IOL CATARACT LENS; LENS, INTRAOCULAR, TORIC OPTICS

Device Problem Use of Device Problem (1670)

Patient Problems Corneal Edema (1791); Red Eye(s) (2038); Blurred Vision (2137); Halo (2227); Eye Pain (4467)

Event Date 06/04/2020

Event Type  Injury  

Event Description

Wrong cataract iol lens impl.At a dr.(b)(6), ophthalmologist at (b)(6) medical outpatient clinic implanted the wrong cataract lens implanted.I had my rt.Eye done 1st with brown tint.Now my lt.Eye has a blue tint with the wrong iol implanted.I had a second surgery to correct the 1st mistake the wrong implanted are causing.The blue tint was added after the second surgery.I have or had severe corneal swelling, blurring of vision with piercing pains shooting through at random times.Mediations had no agreement's meet.I believe the manufacturer of the cataract iol len, (b)(6) facility and / or staff is equally at fault.My doctor had a staff that was telling inappropriate jokes and had to ask me if i was okay.So i don't think the fault lies with only dr.(b)(6).Both surgeries my lt.Eye turned fire and dark red.Hopefully i can send the pictures.I tried getting a second opinion that doctor came in the room and started to ask me about statue of limitations, telling me about illnesses that by me being (b)(6) can cause problems with my eyes and the blue is just a halo i developed.So, i really haven't been able to get a third opinion i can trust.I have developed a $(b)(6) monthly bill because of this.My husband is a retired (b)(6) worker and i am disable from health issues i will send that (b)(6) also caused.Will try to send more.I scare my grand kids now, at times my eye looks like a deadfish is what my grand says it looks like.No one wants to scare their grand kids.The second opinion doctor stated well at this time it's not looking like that.Really at that moment.Fda safety report id # (b)(4).

• Brand Name: TORIC IOL CATARACT LENS
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• MDR Report Key: 14257470
• MDR Text Key: 290528499
• Report Number: MW5109433
• Device Sequence Number: 1
• Product Code: MJP
• 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: 04/27/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ESTRADIOL; LACTULOSE; LEVOTHYROXINE; MORPHINE 15 MG; MURO OILMENT AND DROPS; OXYCODONE 5 MG; TRIANTERINE BLOOD PRESSURE; VITAMIN C
• Patient Outcome(s): Other; Disability; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American, American Indian Or Alaskan Native