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

Model Number	DRN00V
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the preloaded multifocal intraocular lens (iol) was fully implanted in the patient¿s right eye, it was noticed that the lens was scratched from the inserter.The lens was subsequently removed and replaced during the same procedure without any harm to the patient.No unplanned interventions, such as incision enlargement, sutures, or vitrectomy, and no medication or medical attention beyond the standard care was required.There was no delay in the procedure.Daily activities were not significantly affected.Directions for use were followed.The patient is fully recovered.No further information was provided.
Additional Manufacturer Narrative
Section a4: weight: unknown/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; 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 the review, if there is any further relevant information a supplemental medwatch will be filed.An attempt was made to obtain the missing information; however, no additional information was provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information received: additional information was received which reported that it was unknown if the damaged, scratched lens was due to use error.It was reported that the cartridge did not touch the eye.The procedure was completed with a backup lens of different model and diopter (ar40e, 17.5 diopter).It was reported that the device did not cause or contribute to the event.No further information was provided.The product was received for evaluation.The following fields were updated accordingly: section d9: device available for evaluation? yes section d9: date returned to manufacturer: nov 17, 2025 section h3: device evaluated by manufacturer: yes device evaluation: visual inspection under magnification was performed on the suspect product and found the plunger rod fully retracted with viscoelastic residue observed throughout the cartridge.The cartridge tip and cartridge were damaged.No issues were identified with the lens module, device assembly, plunger rod, and plunger rod advancement.No lens was received for evaluation.No further evaluation was performed.The complaint issue was not identified during product evaluation as no lens was received for evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.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 & 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: 23560233
• Report Number: 3012236936-2025-000296
• Device Sequence Number: 10114199
• Product Code: MFK
• UDI-Device Identifier: 05050474810747
• UDI-Public: (01)05050474810747(17)280512
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 12/19/2025

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?: 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: 10/22/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• 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: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White