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

Model Number	DRN00V
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: date of event: unknown, not provided.The best estimate date is between mar 5, 2024, and feb 17, 2025.Device evaluation: product testing could not be performed since the device was not returned for evaluation.Therefore, the reported issue could not be verified, and no product quality deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.No escalation required.Conclusion: based on the complaint investigation results, no product deficiency or product malfunction were found.Attempts have been made to obtain additional information regarding the event; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a multifocal intraocular lens (iol) was explanted from a patient's right eye due to mechanical failure.New incision was made, the lens was taken out whole and a new iol was implanted in the sulcus.No sutures, no vitrectomy, and no patient injury reported.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9.Device available for evaluation? yes returned to manufacturer on apr 18, 2025 section h3.Device evaluated by manufacturer? yes device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification was performed on the suspect product.The lens was received covered in lint from the gauze.The lens was cleaned revealing no issues that could cause or contribute to the complaint issue reported.No further evaluation was performed.The complaint issues reported could not be confirmed during product evaluation, and no issues were identified.Based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.No nonconformity report, documentation or labeling changes, and escalations are required.Johnson & johnson surgical vision will continue to monitor these types of complaints.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Customer described the "mechanical failure" as the patient described symptoms of dark shadows with side vision.Symptoms were first noticed on mar 27, 2024.The replacement lens was a competitor's lens (model number li61ao / 24.0 diopter/ serial number 4260606032).Patient outcome status has improved.Additional codes added: section h6: health effect - clinical code: 2140 - visual disturbances corrected data: the following codes are no longer applicable: section h6: device code(s): 1384 - mechanical problem section h6: health effect - clinical code: 4582 - no clinical signs, symptoms or conditions 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: 21612838
• Report Number: 3012236936-2025-000074
• Device Sequence Number: 18066089
• Product Code: MFK
• UDI-Device Identifier: 05050474810860
• UDI-Public: (01)05050474810860(17)260814
• 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
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 06/16/2025

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 Expiration Date: 08/14/2026
• Device Model Number: DRN00V
• Device Catalogue Number: DRN00V0250
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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: AMVISC VISCOELASTIC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female