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 Codes	Visual Impairment (2138); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A surgeon reported of a patient who was upset with the results and had an unexpected outcome with the preloaded multifocal intraocular lens (iol).The doctor had a plan to perform a laser vision correction to treat the patient's residual refractive error.He targeted a postoperative outcome of plano but resulted in a refractive outcome of ¿1.5.The patient had no history of prior refractive surgery, no pre-existing ocular conditions, and had not undergone any corrective procedures such as lasik.No loss of bscva (best spectacle corrected visual acuity) was reported with correction and it was stated that the patient is able to drive.The patient¿s pre-operative refraction was recorded as -1.50+0.75x145, with a pre-operative best spectacle-corrected visual acuity of 20/30-1 and a post-operative best spectacle-corrected visual acuity of 20/20+2.No unplanned medical or surgical interventions at the time of lens implantation reported.Through follow up it was indicated that the lens was explanted from patient¿s left eye on (b)(6) 2026.The replacement lens was a monofocal lens, model dcb00 with 20.5 diopter.During the explant no unplanned surgical interventions, such as unplanned vitrectomy, incision enlargement or sutures required.No medication outside the standard of care was necessary.The patient's current outcome status day one was reported as 20/50 which stated to be typical day one after an explant but her distance vision is already better than with the prior lens.No further information was provided.
Additional Manufacturer Narrative
Section a4: weight: unknown, information was requested but not provided.An attempts was made to obtain missing information; however, the information was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section h3: device evaluated by manufacturer: yes.Device evaluation: the product was received by the manufacturing site for evaluation and testing.The lens was received cut in half and stored in a specimen container with fluid.The miq (measuring intraocular lens quality) remeasurement confirmed that the lens met specification.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The lens cut observed during product evaluation could not be confirmed to be related to the manufacturing or design process.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search of complaints related to this production order (po) was performed.The search revealed that no other complaints were received for this po.Conclusion: based on the investigation, no malfunction or product deficiency was identified.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: 24671284
• Report Number: 3012236936-2026-000071
• Device Sequence Number: 16006119
• Product Code: MFK
• UDI-Device Identifier: 05050474810778
• UDI-Public: (01)05050474810778(17)271211
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2026
• 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): 04/24/2026

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: DRN00V0205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2026
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White