MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DRN00V
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: female.Section a-4 patient weight: unknown/asked information was not provided.Section a-5 patient ethnicity: unknown/asked information was not provided.Section a-6 patient race: unknown/asked information was not provided.Section d-6b date explanted: not applicable as the iol remains implanted; therefore, not explanted.Section h-3 device evaluated by manufacturer: the complaint device was not returned for evaluation as it 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 the review, if there is any further relevant information a supplemental medwatch report will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
While inserting the drn00v model intraocular lens (iol) in the patient¿s ocular dexter (right eye), the injector did not release, the iol did not fully insert, and the trailing haptic did not completely emerge from the inserter.The lens was delivered upside down and required manual manipulation to flip the iol.The wound was not enlarged, and no vitrectomy was performed.On the same day post-operation, visual acuity was measured at 20/40 with dilation and minimal stria.By on (b)(6) 2026, three days after the operation, visual acuity had improved to 20/20-1 with j3 reading ability.A follow-up appointment was scheduled for on (b)(6) 2026.The suspect iol is not available for investigation as it remains implanted.No further information is available.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 24787147
• Report Number: 3012236936-2026-000087
• Device Sequence Number: 6134034
• Product Code: MFK
• UDI-Device Identifier: 05050474810839
• UDI-Public: (01)05050474810839(17)280430
• 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: 2026
• 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): 04/06/2026

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: DRN00V0235
• 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: 03/13/2026
• Initial Report FDA Received Date: 04/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2025
• 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
• Patient Age: 78 YR
• Patient Sex: Female