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

Model Number	DRN00V
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4 and a5: unknown/ not provided.Section h3: the device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.H6: health effect - impact code: 4625: 4625 - additional surgery: suture.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported by the doctor that a crack was discovered in the lens in the patient's eye.The patient returned complaining of poor vision, and the crack was identified upon reexamination.The crack had not been seen by the implanting doctor due to leftover cortex and lens fragments.The patient then consulted a different doctor, who requested an explant.During the explant procedure, due to the patient's anatomy, the lens became caught in the capsule, resulting in a capsular tear.This complication necessitated the implantation of a 3-piece lens sutured into the sulcus.The lens was subsequently removed and replaced with another company's iol during a secondary surgical procedure.The patient required incision enlargement, vitrectomy, and sutures.The patient's outcome was as follows: no edema, visual acuity of 21/25, intraocular pressure (iop) of 8 mmhg, and mild vitreous hemorrhage.No further information is available.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: no.Section d-9: device date returned to manufacturer: not returned.Section h-3: device evaluated by manufacturer: photo evaluated.Device evaluation: a customer photo was evaluated.The photo displayed the suspect lens inside the patient's eye.A crack-like mark was observed near the top right of the lens.Scratches were also observed on the lens.Due to no product received, no further evaluation could be performed.The complaint issue was identified during photo evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Upon further review and additional information, the surgeon notified that the patient's issue was due to intraocular lens (iol) positioning, not the crack(s).The following fields have been updated accordingly.Remove device code: 1069 - break and replaced with device code(s): 2923 - device dislodged or dislocated.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: 22406810
• Report Number: 3012236936-2025-000172
• Device Sequence Number: 9978141
• Product Code: MFK
• UDI-Device Identifier: 05050474810792
• UDI-Public: (01)05050474810792(17)271020
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRN00V
• Device Catalogue Number: DRN00V0215
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 07/18/2025; 08/12/2025
• Initial Report FDA Received Date: 07/04/2025
• Supplement Report FDA Received Date: 08/13/2025; 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2024
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 98 KG