MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS SIMPLICITY; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DRN00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h3, device evaluated by manufacturer: the device has not been returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending 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 the patient¿s right eye.The patient stated that their distance vision was very blurry.The doctor planned on removing the iol at a later date (b)(6) 2025 and replacing it with the same model but different diopter, drn00v 31.0 diopter.Reportedly, there were no complications such as a capsule tear, incision enlargement, vitrectomy, or sutures.Their preoperative uncorrected and best corrected visual acuity was reported as ¿count fingers uncorrected and 20/25 corrected.¿ their postoperative uncorrected and best corrected visual acuity was reported as ¿20/120 uncorrected and 20/25 corrected.¿ the initial iol was subsequently removed.The replacement lens information was not provided by the customer and the patient outcome is unknown.Consequently, for the other eye, the doctor performed an adjustment to their calculations to account for the patient¿s myopic surprise with the first lens in the right eye.No further information is available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jan 29, 2026.Section h3: evaluated by manufacturer? yes.Device evaluation: the complaint lens was received.Visual inspection under magnification revealed that the lens was cut in half and coated in an unknown liquid.The lens halves were cleaned revealing a detached haptic.The physical characteristics of the received lens was confirmed to match that of a drn00v model lens.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 24196617
• Report Number: 3012236936-2026-000026
• Device Sequence Number: 10177778
• Product Code: MFK
• UDI-Device Identifier: 05050474811034
• UDI-Public: (01)05050474811034(17)270125
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: DRN00V
• Device Catalogue Number: DRN00V0335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Race: White