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 Headache (1880); Hypersensitivity/Allergic reaction (1907); Red Eye(s) (2038); Blurred Vision (2137); Visual Disturbances (2140); Contact Dermatitis (4546); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

It was reported that after the preloaded intraocular lens (iol) was implanted in the right eye (od), the patient had an intense allergic reaction.It was noticed that something was ¿not right¿ just after the lens was implanted in the od, however the patient waited until (b)(6) 2023 before knowing for sure that something was wrong.Symptoms included wiggly vision, swollen od, burning sensation, and contact dermatitis on the side of nose, underneath eye and up until the eyelid od.Other symptoms include headache, tight chest, runny nose, itchy scalp, eyes, and ears.The contact dermatitis has progressively gotten worse underneath pinky finger, thumb, roof of mouth, scalp, and ears since (b)(6) 2023.The patient reported the vision od is very unstable ¿ ¿shaky and discombobulated on the sides¿ and the patient is having to work hard to see clearly.The center vision is okay.The patient reported being ¿totally debilitated¿ and is in an ¿inordinate amount of pain¿.The patient is very hesitant to drive and must wear three pairs of sunglasses inside and outside of the house.The patient had to use medication, specifically benadryl, albuterol, zyrtec, and eye lubricant drops to try to relieve symptoms.The patient has been in constant contact with the doctor, who prescribed a high dose prednisone (to be tapered) to begin using on (b)(6) 2023, to treat the allergic reaction.The prednisone only seems to help bring down the contact dermatitis and nothing seems to help the other symptoms.The patient believes the implanted lens is causing the allergic reaction symptoms, as the patient had these same symptoms with a previously implanted dental implant which was due to an allergy to resin methyl methacrylate.When the dental implant was removed, the symptoms stopped.The patient also reported having cataract surgery and a lens implanted in the left eye, with no issues.The patient is happy with the left eye.The patient visited the doctor on (b)(6) 2023, and was told the lens is in proper place and there is no abnormal inflammation in the right eye.The patient saw another doctor on (b)(6) 2023, because the jaw is getting hard to move and per the doctor the patient¿s inner ears are swollen and have raw patches of red splotches.The patient also has a history of lupus.On (b)(6) 2023, the patient is scheduled to see an inflammation specialist ophthalmologist, who has previously seen the patient.The patient provided a list of current medications.Medication list (as of (b)(6) 2023): albuterol sulfate 108 (90 base) mcg/act aerosol powder 2 puff, inhalation, q4-6hr, prn, prn as needed for wheezing, 1 each; amitriptyline 25 mg tablet (commonly known as: elavil) take one tablet by mouth nightly; amlodipine 5 mg tablet (commonly known as: norvasc); budesonide-formoterol 80-4.5 mcg/act inhaler (commonly known as: symbicort) inhale 2 puffs 2 (two) times a day.Rinse mouth with water after use to reduce aftertaste and incidence of candidiasis.Do not swallow.; cetirizine hcl 10 mg capsule 10 mg per, oral, prn (as needed); diphenhydramine 12.5 mg chewable tablet (commonly known as: benadryl) chew 12.5 mg every 6 (six) hours as needed for allergies.; fluconazole 150 mg tablet (commonly known as: diflucan); fluorometholone 0.1 % ophthalmic suspension (commonly known as: fml) administer one drop in the effected eye 2 times a day for 1 week then once a day for 1 week and discontinue.; fluticasone 50 mcg/act nasal spray (commonly known as: flonase) administer 1 spray into each nostril daily.; hydrocodone-acetaminophen 5-325 mg per tablet (commonly known as: norco) take 1 tablet by mouth every 6 (six) hours as needed for moderate pain.; hydroxychloroquine 200 mg tablet (commonly known as: plaquenil) take 200 mg by mouth.; ibuprofen 800 mg tablet (commonly known as: advil,motrin) 800 mg per 1 tablet, oral, prn (as needed), prn prn for pain; ilevro 0.3 % suspension (generic drug: nepafenac) administer 1 drop into the left eye once daily.Start 2 days before surgery and use until bottle runs out.; ipratropium 0.03 % nasal spray (commonly known as: atrovent) 2 sprays/nostril tid (three times a day) prn drainage; levothyroxine 137 mcg tablet (commonly known as: synthroid) take 137 mcg by mouth.; lorazepam 1 mg tablet (commonly known as: ativan); omeprazole 40 mg capsule; *prednisolone acetate 1 % ophthalmic suspension (commonly known as: pred forte) after surgery use in left eye 4 times/day for 1 week, then 3 times/day for 1 week, then 2 times/day for 1 week, then 1 time/day for 1 week.; *prednisolone acetate 1 % ophthalmic suspension (commonly known as: pred forte) administer 1 drop into the right eye in the morning and 1 drop in the evening.; prednisone 20 mg tablet (commonly known as: deltasone) take 3 tablets po daily for 3 days, then 2 tablets po daily for 3 days, then 1 tablet po daily for 3 days, then 1/2 of a tablet po daily for 3 days then stop.; vagifem 10 mcg tablet (generic drug: estradiol); vitamin d3 po daily; zolpidem 10 mg tablet (commonly known as: ambien) 10 mg per 1 tablet, oral, qhs (each night at bedtime), prn prn for sleep.No further information was provided.

Manufacturer Narrative

Section b3: date of event: unknown; requested but not provided.The best estimate date is between (b)(6) 2023, as the patient mentioned noticing an issue right after surgery, then waited and confirmed the issue on (b)(6) 2023.Section d6b: if explanted, give date: not applicable, as the lens remains implanted.Section h3-other (81): 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.An attempt was made to obtain missing information; however, the consumer did not provide the information.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: 17954421
• MDR Text Key: 325897261
• Report Number: 3012236936-2023-02646
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474731783
• UDI-Public: (01)05050474731783(17)260429
• 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: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0215
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2023
• 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): Required Intervention
• Patient Sex: Female
• Patient Weight: 114 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White