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

Model Number	DRN00V
Medical Device Problem Codes	Break (1069); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3, a4, and a5: unknown, as information was requested but not provided.Section d6a: implant date: not applicable, as there is no indication that the lens was implanted.Section d6b: explant date: not applicable, as there is no indication that the lens was implanted.Section e1: telephone number: (b)(6).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 this review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during the implantation of the preloaded intraocular lens (iol), the iol was extruded in an excessively bent configuration.Therefore, the iol was not used.The account reported resistance when pushing out the iol.The procedure was completed successfully with a replacement device.No patient injury was reported.No other medical intervention was required.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: january 5, 2026.Section h3 - device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification was performed on the suspect product.The plunger rod was found advanced to a lens that was stuck in the cartridge.A torn off lens portion was received on top of the cartridge.Viscoelastic residue was not observed to be evenly distributed throughout the cartridge indicating that an inadequate amount of ophthalmic viscosurgical device (ovd) may have been used, which could contribute to the complaint issue.The cartridge and cartridge tip were damaged.No issues were identified with the lens module, device assembly, plunger rod, or plunger rod advancement.The torn off lens piece was cleaned, revealing that the lens was damaged and scratched, and a portion of a haptic was detached.No further evaluation was performed.The complaint issue "lens damaged" was identified during product 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 complaint issue "difficult to use" was not identified.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: 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 and 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: 23946783
• Report Number: 3012236936-2026-000003
• Device Sequence Number: 7874565
• Product Code: MFK
• UDI-Device Identifier: 05050474810587
• UDI-Public: (01)05050474810587(17)280430
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: DRN00V0110
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2025
• 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 Sex: Unknown