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	Eye Injury (1845)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4, a5, a6, patient information: unknown/not provided.Section h3, device evaluated by manufacturer: the device has not been returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain the missing information.However, to date, it 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 the preloaded multifocal intraocular lens (iol) was explanted from a patient's operative eye in a secondary surgical procedure.The reason for explant was not specified.The explanted lens was replaced (the information about the replacement lens was not provided).The patient outcome status is unknown.No further information was provided.
Event or Problem Description
The intraocular lens (iol) was implanted into the right eye.The patient experienced halos and glare which made it impossible to drive at night causing strain and headaches.The iol was explanted and replaced.There were no complications such as a capsule tear, vitrectomy or sutures required and no medication outside the standard of care was needed.The customer indicated that they plan on returning the product.The patient declined to specify their race and ethnicity.No further information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review it was noticed that the following information was received through follow-up with the customer.The initial report should have included the following information.This current report provides the additional information and correction below.Section a5, ethnicity: the patient declined to specify.Section a6, race: the patient declined to specify.Section b5, describe event or problem: the intraocular lens (iol) was implanted into the right eye.The patient experienced halos and glare which made it impossible to drive at night causing strain and headaches.The iol was explanted and replaced.There were no complications such as a capsule tear, vitrectomy or sutures required and no medication outside the standard of care was needed.The customer indicated that they plan on returning the product.The patient declined to specify their race and ethnicity.No further information was provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: feb 24, 2026.Section h3: evaluated by manufacturer? yes.Device evaluation: the complaint lens was received.The lens was visually inspected revealing that the lens was cut in four pieces and coated in viscoelastic reside.No further issues were identified.During the product evaluation it was confirmed that the physical characteristics of the lens matched a drn00v model lens.Based on the complaint investigation results, the product was released within specifications.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: 24050193
• Report Number: 3012236936-2026-000016
• Device Sequence Number: 9745124
• Product Code: MFK
• UDI-Device Identifier: 05050474810785
• UDI-Public: (01)05050474810785(17)280312
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 04/17/2026

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 Model Number: DRN00V
• Device Catalogue Number: DRN00V0210
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 01/20/2026; 03/20/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 01/20/2026; 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male