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

Model Number	DCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Flashers (1864); Local Reaction (2035); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3, date of event: the patient explained that her symptoms started right after the first implant (right eye (b)(6) 2025) but they were not as severe until the second eye was done because now, she has two eyes that don¿t work.Section d6b, if explanted, give date: not applicable as the lens remains implanted.Section h3, device evaluated by manufacturer: 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 and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the johnson and johnson (jnj) intraocular lens (iol) was implanted into both the patient¿s left and right eye.The patient explained that her symptoms started right after the first implant (right eye (b)(6) 2025) but they were not as severe until the second eye was done because now, she has two eyes that don¿t work.They can see well when looking straight ahead.If she changes her view she sees waves, prisms, and vision is blurry.The degree varies depending on the light she is in.This causes her to feel dizzy and affects her depth perception.Patient has trouble standing, cannot drive, is losing her balance and falling.She has accidentally cut her fingers when cutting vegetables.Reportedly, her doctor said she may be seeing out the side of the lens.She cannot see through the lens material and indicated she may need a different lens made of a different material.Patient was prescribed brimonidine tartrate ophthalmic solution which was initially helpful.However, she was found to be allergic which resulted in dropped blood pressure and excessive fatigue.She has discontinued this medication and started using a different eye drop.With the eye drops her vision is much better for hours.After applying the drops her vision is better than it's ever been.However, with the light her vision gets blurry.She didn't have these problems before the implants.The patient explained that her symptoms started right after the first implant but they were not as severe until the second eye was done because now, she has two eyes that don¿t work.The patient tried using different progressive lenses and 2 other corrective eye glass lens types that didn't work.The patient is considering an explant.However, her doctor wants to wait at least a year because the symptoms may resolve.The doctor does not want to remove the lens.She has been diagnosed with multiple sclerosis (ms) neurosarcoidosis which is affecting her brain and spinal cord.Patient has had osteoporosis, breast cancer, footdrop in one leg and hyperactive reflexes that required treatment.She has progressively increasing body weakness.Reportedly, the loss of vision has required her to use a wheelchair regularly to ensure she does not fall.She is concerned that the iol implants triggered an autoimmune response.No further information is available.This report captures the right eye.The left eye is manufacturer report number 3012236936-2026-0001877.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: 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: 25661705
• Report Number: 3012236936-2026-000187
• Device Sequence Number: 20259233
• Product Code: HQL
• UDI-Device Identifier: 05050474636033
• UDI-Public: (01)05050474636033(17)280802
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000175
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White