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 Codes	Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the preloaded multifocal intraocular lens (iol) was explanted from the left eye (os) due to the patient¿s inability to adapt to the iol power, which affected the patient's life and caused difficulty with near vision and the inability to read without additional correction.It was reported that there was a loss of two or more lines of best spectacle corrected visual acuity (bscva) for near acuity.Another johnson and johnson iol was implanted as replacement; same model, different diopter of 22.5.No unplanned surgical interventions were required and no medications outside the standard of care were prescribed.The patient¿s pre-operative (pre-op) refraction was -0.50 -0.50 x 152 and bscva of 20/20.The patient¿s post-operative (post-op) refraction was +0.75 -0.50 x 150 and bscva of 20/20.The intended target refraction was +1.00.The patient¿s post-op refraction following the lens exchange was 20/40 os and 20/20 ou (both eyes) on day one post-op.The patient did not have any pre-existing conditions that affected calculation.The patient was not over correction or under correction.The outcome of the patient was reported as successful.The patient is scheduled to return for another post-op exam on (b)(6) 2025.It was reported that the device did not cause or contribute to the event.The device was discarded.No further information was provided.
Additional Manufacturer Narrative
Section b3: date of event: unknown/not provided.The best estimate date is between jun 19, 2025, and nov 13, 2025.Section h3: the device was not returned for evaluation as it was discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending 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, no further information has been received.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: 23761041
• Report Number: 3012236936-2025-000328
• Device Sequence Number: 15972455
• Product Code: MFK
• UDI-Device Identifier: 05050474810792
• UDI-Public: (01)05050474810792(17)270613
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2025

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: DRN00V0215
• 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: 11/17/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White