MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

Model Number DIB00

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

Patient Problems Flashers (1864); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Swelling/ Edema (4577); Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that the patient is experiencing positive and negative dysphotopsia with intraocular lens (iol) in her right eye post iol implant.The patient described experiencing a vibration in her eye since surgery.She said it is not visible to someone looking at her.It is related to how her eye is catching the reflection of light with the new lens.She feels her brain is not adapting to the new lens.She stated she sees dark spots that are more like magnified water droplets or black lines with a halo behind it.The patient sees as a ghost image on her left side, that is not just in the corner, but closer to the inside too.When she blinks it feels like it is out of focus.She said it is not, double vision, but a ghost vision.This makes her feel anxious and dizzy.She is concerned about driving.She said she can drive, but does not feel comfortable doing so because the aberrations make her feel like she can not see.The patient mentioned she experienced a lot of edema after surgery.She spoke to her doctor, who said the lens is attached correctly and she is healing perfectly.He did not know what was causing her visual disturbances, but was going to reach out to johnson & johnson for answers.He mentioned potentially exchanging the lens, but she really does not want to do this, because of her experience with this eye.She also said she may just let her left eye go blind instead of having surgery.The patient feels the lens is doing its job and noticed right after surgery, she cried because the colors were so vivid.Although she can see well in her home and in the dark, she does not see as well as she would like in other situations.The patient has not noticed an improvement in her distance vision, cannot read her cell phone, and the interior of her car is not as clear; however it is better than when she had before the cataract.She is using prescription glasses to see up close, and uses sunglasses to assist with the glare (which is described as a bright white light).This is in addition to the issues mentioned above.She is taking argentyn23 by choice, a homeopathic medication which she described as an antiviral medicine she used to help with styes and eye cysts.She said after surgery it eased discomfort she felt.She called the manufacturer of argentyn23 and they said to reach out to the manufacturer of the lens.She asked her surgeon and her regular doctor and they did not know if she would react with medication and iol.The patient enjoys using this, and wants to continue.However, she wants to make sure this is not contributing to her visual issues.She thinks she had dense cataracts.She was prescribed 5% sodium drops for edema after the surgery called amero.In addition, she is taking pred-moxi 4 x day and prolenta x 1 a day, which she said were anti-inflammatory medications.The patient has not spoken to a pharmacist regarding any negative interactions between these medication and the argentyn23.The patient said she has always been light sensitive, even before surgery.She is a visual artist by occupation.She has no other health or eye health issues.Through follow-up, it was learned that her doctor diagnosed her with negative dysphotopsia and positive dysphotopsia.The patient did not know the location of her edema, nor, did not know if the edema persists.However, the patient confirmed she is still taking saline drops for the edema and is not part of standard of care.The patient also confirmed the anti-inflammatory medications: pred-moxi 4 x day; prolenta x 1 a day, were standard of care medications her doctor prescribed after surgery.The patient's vision has cleared a bit, but now she is dealing with a chalazion cyst which is interfering with her vision.The patient mentioned she has had a history of having a chalazion cyst.Therefore, she has seen her doctor weekly due to the cyst.The patient stated she is taking a homeopathic, antiviral medicine called argentyn 23.Argentyn 23 has helped her with the cyst before and continues to use it to treat the chalazion eye cyst.As for now, the lens remains implanted.The patient is not willing to do any other surgery until her cyst goes away.Her doctor has given her the option to either exchange the lens or do a reverse optic capture if she continues to have these visual issues.However, patient made it very clear she is not making any decisions until her cyst is gone.No other information was provided.

Manufacturer Narrative

Date of event: best estimate date (b)(6) 2022.If explanted; give date: n/a (not applicable).The lens remains implanted.The device was not returned for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.(b)(4).Attempts were made to obtain the missing information; however, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 14350294
• MDR Text Key: 294673600
• Report Number: 3012236936-2022-01225
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474731868
• UDI-Public: (01)05050474731868(17)240220
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female