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

Model Number	DRN00V
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a preloaded multifocal intraocular lens (iol) was noted to be damaged during the injection process.The surgeon rotated the implanted lens so the defect was positioned superiorly to mitigate potential clinical impact.The procedure was completed without interruption and the lens remains implanted.No further information was provided.
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5 and a6: unknown, information was requested but not provided.Section d6b: if explanted; give date: not applicable as the device remains implanted.Section h3: the device was not returned for evaluation as the lens remains implanted; 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.Attempts have been made to obtain missing information; however, to date, the information has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information received which the following fields were updated accordingly: section a2: age: 69 years.Section a2: date of birth: (b)(6) 1956.Section a3a: sex: female.Section a3b: gender: cisgender woman/girl.Section a6: race: white.Section b5: additional information confirmed that the optic was damaged, while the tip of the cartridge was not.The damaged part or the peripheral optic rotated superiorly.The doctor did not feel any resistance during delivery of the lens.It was stated that the damage was not due to use error.The lens remains implanted in the patient's left eye to date with no visual issues.The patient was informed of this issue and is under observation.There were no patient injury or any complications such as capsule tear, unplanned vitrectomy, incision enlargement or sutures and no medication outside the standard of care required.The patient was reported to have good outcome.During preparation of the device, the lubrication used was ophthalmic viscoelastic device (ovd) "provisc" which was introduced in the cartridge from the cartridge canopy.The average dwell time/keeping in the dwell position was 3 minutes.The surgery tech does the first twist, but it is unknown if uninterrupted once the lens has passed the dwell position and when advancing the lens, complete turn is made.Section d10: concomitant medical products: provisc.Section e1: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: no suspect product was received; however, the customer provided photos were evaluated.The pictures show 2 scratch/crack like marks with triangular shape located in the lens periphery at 4:00 and 5:00 in relation to the picture orientation.Although, per the marks location it is not expected for them to impact the patient visual function, the actual clinical impact as well as the root cause of the reported incident cannot be determined from a picture assessment.The complaint issue "lens damaged" 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.Conclusion: based on the investigation, no 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: 23764892
• Report Number: 3012236936-2025-000331
• Device Sequence Number: 10562120
• Product Code: MFK
• UDI-Device Identifier: 05050474810785
• UDI-Public: (01)05050474810785(17)280410
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 03/11/2026

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: DRN00V0210
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 12/12/2025; 02/17/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/06/2026; 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROVISC.
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: White