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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a3b, a4 and a5: unknown/ asked but not available.Section d6b: if explanted, give date: not applicable, as lens remains implanted in the eye.Section h6 - health effect - clinical code 4581: no code available (incision enlargement).Device evaluation: product testing could not be performed since the device was not returned for evaluation (lens remains implanted).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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported by the surgeon that the inserter of the preloaded intraocular lens (iol) could not fit through the 2.4 incision in the right eye of the patient.The incision was enlarged and iol was implanted.However, the lens was found to be scratched.The patient is fine and the iol remains implanted in the patient's eye; there are no plans to explant the device.There were no medical/surgical intervention required.The patient is doing fine.No further information is available.
Additional Manufacturer Narrative
Upon further review the medical device problem code dc-difficult to use-1487 is added.Hence a correction report would be submitted for us with aware date being 4/17/2025, the date of reassessment.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: 21690508
• Report Number: 3012236936-2025-000077
• Device Sequence Number: 15636073
• Product Code: MFK
• UDI-Device Identifier: 05050474810747
• UDI-Public: (01)05050474810747(17)270905
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 04/24/2025

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?: 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: 02/25/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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: 78 YR
• Patient Sex: Female