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	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a surgical procedure the preloaded multifocal intraocular lens (iol) was implanted into the patient¿s left eye.After the implantation, a tear in the capsule was identified, requiring the lens to be explanted during the same surgery.Enlargement of incision and vitrectomy were required, and this was unplanned.It was stated that sutures are standard practice after this procedure.The lens was replaced during the same procedure with a non-johnson & johnson lens of +19.0 diopter.No medication outside of the standard of care was required.The account is uncertain if the patient had any pre-existing issues or if the device caused or contributed to the event.The patient is currently recovering well with a monofocal iol placed in the sulcus, without experiencing any temporary or permanent impairment and daily activities have not been significantly affected.The explanted lens was discarded and is not available for return.No further information was provided.
Additional Manufacturer Narrative
Section a5 and a6: unknown, information was requested but not provided.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same surgery.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 this review, if there is any further relevant information, a supplemental medwatch will be filed.Section h6- health effect - clinical code 4581 - no code available (incision enlargement).Section h6: health effect - impact code: 4625 - this code was used to capture incision enlargement & vitrectomy.An attempt was made to obtain additional information regarding the event; however, the information was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in review, it was noticed that the following information was inadvertently not included in the initial mdr report; therefore, the information has been captured in this supplemental mdr report as indicated below: section h6: health effect - impact code: 4625 - this code was used to capture sutures.Additional information: historical data analysis: a search of complaints related to this production order (po) was performed.The search revealed one additional complaint folder was received for this po.However, complaint issues reported are not related.Therefore, no further actions are required.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: 23058377
• Report Number: 3012236936-2025-000245
• Device Sequence Number: 9503790
• Product Code: MFK
• UDI-Device Identifier: 05050474810761
• UDI-Public: (01)05050474810761(17)271128
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

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: DRN00V0200
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2024
• 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 Sex: Male
• Patient Weight: 73 KG