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 Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient expressed dissatisfaction with a preloaded multifocal intraocular lens (iol), citing dysphotopsia and suboptimal visual outcomes.The patient initially presented with a visual acuity of 20/100, which improved to 20/70 following the most recent manifest refraction; however, the patient remained dissatisfied with the outcome.An attempt was made by the surgeon to explant and replace the lens; however, the procedure was not completed due to intraoperative identification of delicate zonules, and the iol was left in the patient's eye.The approximate date of this attempted procedure was reported as early april.The cause of the reduced postoperative visual acuity (va) is unknown, and it is unclear whether the reported va of 20/70 was best-corrected or uncorrected.The patient is not reported to have a debilitating condition but remains dissatisfied with the lens.It is also unknown whether the patient had any pre-existing ocular conditions that may have contributed to the outcome.No further information was provided.
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5 and a6: unknown, information was requested but not provided.Section b3: date of event: exact date is unknown/not provided.Best estimate date is prior to apr 17, 2026.Section d6b: if explanted; give date: not applicable as the device remains implanted.Section h3: the device was not returned for evaluation as the lens remains implanted; 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 this review, if there is any further relevant information, a supplemental medwatch will be filed.Attempts have been made with the customer to obtain additional information, however, the information was not available.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: 25154169
• Report Number: 3012236936-2026-000130
• Device Sequence Number: 18830599
• Product Code: MFK
• UDI-Device Identifier: 05050474810815
• UDI-Public: (01)05050474810815(17)280617
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: DRN00V0225
• 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: 04/17/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2025
• 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: Other
• Patient Sex: Unknown