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 Code	Visual Impairment (2138)
Date of Event	10/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h3 (no): the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.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 left eye because of specific visual issues.The patient reported that near, intermediate, and night vision were blurry and fuzzy.A non-johnson & johnson lens of 16.0 diopter was used as a replacement.No additional medical or surgical interventions such as vitrectomy, sutures, or incision enlargement was required.There was no patient injury reported.It was indicated that the patient is doing better, improved.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 performed on the suspect product found that the lens was cut in half and coated in viscoelastic residue.The lens halves were cleaned revealing a mark on the edge of one lens half.No further evaluation was performed.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The other issues observed could not be confirmed to be related to the manufacturing or design process.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 further 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.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: 21434846
• Report Number: 3012236936-2025-000050
• Device Sequence Number: 20010629
• Product Code: MFK
• UDI-Device Identifier: 05050474810679
• UDI-Public: (01)05050474810679(17)260810
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2024
• 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: 08/10/2026
• Device Model Number: DRN00V
• Device Catalogue Number: DRN00V0155
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White