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	Blurred Vision (2137); Posterior Capsule Opacification (4807)
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported regarding the johnson and johnson (jnj) intraocular lens (iol).The patient¿s cousin, who is an ob-gyn doctor, reported to johnson and johnson that the patient had johnson and johnson intraocular lenses implanted in both eyes and experienced significant vision issues three weeks after the implantation.This report captures the left eye.The patient reported blurry vision in the light, the inability to see at night, and increasing difficulty with daily farming activities.Including operating machinery and driving which affects his independence and safety.The patient resides in a farming community.Reportedly, the patient¿s physician advised waiting six months for a laser procedure due to a film developing over his eyes.The patient¿s cousin expressed dissatisfaction with ophthalmic care practices in their state, specifically noting that optometrists, rather than ophthalmologists, are directing patient care.He reported that patients' may not be directly consulting with surgeons prior to procedures.He is concerned about the process, suggesting that other farmers in the area have experienced similar vision problems and questioned whether there may be an issue with the lens itself.He inquired about studies related to the dcb00 lens and was informed that the lens is approved by the united states food and drug administration, with product information available online.The reporter expressed a willingness to escalate the matter to the media or pursue a medical class action lawsuit against johnson and johnson if his concerns were not addressed and declined to provide further details unless he could speak with higher management at johnson and johnson.A jnj supervisor followed up with a phone call, during which both the complaint reporter and the patient participated, providing event details and confirming the patient¿s experience.The conversation concluded with assurances that the complaint would be monitored, and the patient¿s cousin would provide updates if the patient¿s condition changed.No product return was requested as it remains implanted.Reference was made to the dcb00 lens and its regulatory status.No further information was provided.Right eye manufacturer report number 3012236936-2026-0001676 left eye manufacturer report number.
Additional Manufacturer Narrative
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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 25446779
• Report Number: 3012236936-2026-000173
• Device Sequence Number: 9533554
• Product Code: HQL
• UDI-Device Identifier: 05050474636118
• UDI-Public: (01)05050474636118(17)281105
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: DCB0000215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2025
• 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 Sex: Male