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	05/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h3: the device was not returned for evaluation; 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after the preloaded multifocal intraocular lens (iol) was implanted in the left eye, the patient experienced poor computer and reading vision.The patient reported an inability to perform nighttime driving post-surgery.The issue was identified during a post-operative examination.The pre-operative (pre-op) refraction was 20/25-2 and pre-op best spectacle corrected visual acuity (bscva) was 20/20.The intended target refraction was -0.22.The post-operative (post-op) refraction and bscva with the original lens was 20/20-1.The patient did not experience a loss of two or more lines of bscva, and there was no over- or under-correction.No pre-existing conditions affected the calculation.The lens was subsequently explanted in a secondary surgery and replaced with a non-johnson and johnson iol with +21.0 diopter.No unplanned incisions, sutures, or vitrectomy were performed.There was no delay in procedure and directions for use were followed.There was no patient injury.The patient did not need additional medical attention or medication outside the standard of care.The post-op refraction after the lens exchange was 20/20-1.The patient is fully recovered.Per the account, the device did not cause or contribute to the event.No further information was provided.
Additional Manufacturer Narrative
The product was received for evaluation.Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: dec 11, 2025.Section h3: device evaluated by manufacturer: yes.Device evaluation: two lenses were received inside separate plastic bags with a piece of foam.These lenses were received for the same returned goods authorization (rga).Since it could not be confirmed which event belongs to which lens, both lenses were evaluated in each investigation.Evaluation results are provided in this mdr and in mdr 3012236936-2025-0003048.Visual inspection under magnification was performed on the suspect product and found the first lens (lens #1) was cut in half and coated in viscoelastic residue.The lens was cleaned and inspected, and no further issues were identified.The second lens (lens # 2) was visually inspected and found the lens was cut in half and coated in viscoelastic residue.The lens was cleaned and inspected, and no further issues were observed.Conclusion: based on the investigation results and the available information, no issues that could cause or contribute to the reported events were identified during product evaluation.No product malfunction or product deficiency was identified.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: 23723550
• Report Number: 3012236936-2025-000321
• Device Sequence Number: 10720402
• Product Code: MFK
• UDI-Device Identifier: 05050474810785
• UDI-Public: (01)05050474810785(17)270521
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: DRN00V0210
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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 Weight: 124 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White