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

Model Number	DRN00V
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after implanting the preloaded johnson and johnson (jnj) intraocular lens (iol) into the patient's left eye it was found to be defective.The iol was immediately removed and replaced with a new lens of the same model drn00v 19.0 diopter.There were no complications such as a vitrectomy, incision enlargement or sutures.The patient¿s outcome was reported as stable.No further information was provided.
Additional Manufacturer Narrative
Section a4, a5, a6, patient information: unknown/not provided.Section d6a, if implanted, give date: not applicable as the iol was removed and replaced during the same procedure.Section d6b, if explanted, give date: not applicable as the iol was removed and replaced during the same procedure.Therefore, not explanted.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.
Additional Manufacturer Narrative
Corrected data: based on the new information received, it was learned that the event for serial number (b)(6) was already captured and submitted under the manufacturer report number 3012236936-2025-0001811.At the time of the submission the serial number was unknown but was subsequently received via this new information.No further information will be provided under this manufacturer report number 3012236936-2025-0002122, as it has now been determined to be a duplicate report.Additional information: the doctor¿s first name was provided as (b)(6).Doctor¿s email was updated to (b)(6) and their telephone number is (b)(6).The patient¿s outcome was reported as "good".There was no patient injury or complications and no medical or surgical intervention required.The complaint product is not available for return (discarded).The new information also clarified that the iol touched the eye but did not deploy because it was stuck inside the cartridge.Section e1, first/given name: (b)(6).Section e1, email address: (b)(6).Section e1, telephone number: (b)(6).Section h6, health effect - impact code: 2199 is being used to report no health consequences due to the new information received the iol touched the eye but did not deploy, was not inserted into the eye.Section h6, device code(s): 2983 mechanical jam.Section h6, type of investigation 4115 device discarded.Moving forward any new information received will be reported under manufacturer report number 3012236936-2025-0001811.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: 22720575
• Report Number: 3012236936-2025-000212
• Device Sequence Number: 9393352
• Product Code: MFK
• UDI-Device Identifier: 05050474810747
• UDI-Public: (01)05050474810747(17)280113
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRN00V
• Device Catalogue Number: DRN00V0190
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2025
• 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
• Patient Age: 72 YR
• Patient Sex: Male