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	Blurred Vision (2137); Halo (2227)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a multifocal intraocular lens (iol) was explanted from a patient's left eye due to patient having difficulty with near vision.Patient first noticed struggling to see computer at 1 week post operative (op).At 1 month, the near vision was still the main complaint which the patient was unable to see her phone or computer and could not drive at night because of the halos were so bad, despite satisfactory distance vision.At 2 months post op, the near vision was still blurry.At 4 months post op, same complaint and started to wear readers +1.00 but did not resolve the issue.The patient also experienced issues with depth perception and expressed dissatisfaction, stating that she felt she had traded near vision for distance vision.By (b)(6) 2025, the patient reported no improvement in her near or intermediate vision.Therefore, the iol was explanted and a replacement lens of different model and diopter (dxr00v +20.0d) was used.No medical or surgical intervention required and no patient injury noted.Patient at 1-day post iol exchange, near vision (nv) 20/32, doctor noted "can see her computer".Pre-operative for right eye (od): 20/60, manifest refraction (mr) od: -0.75-0.50x085, 20/20; for left eye (os): 20/80; mr os: -1.25-0.50x095, 20/20, both eye (ou) 20/40, near vision (nv): 20/50 post-operative for od: 20/32, nv: 20/100, for os: 20/32, for ou: 20/20, mr od: +0.25-0.50x100, 20/20; os: +0.25-0.25x024, 20/20.No further information was provided.
Additional Manufacturer Narrative
Section h3: the device was not returned for evaluation; 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information received indicated that the patient also has a johnson & johnson lens in her right eye.However, it was confirmed that there was no issue or complaint with the patient's right eye.Section d9: device available for evaluation: yes section d9: returned to manufacturer on: aug 18, 2025 section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection revealed that the lens was cut in half.No issues were observed that could cause or contribute to the complaint issues reported.The ¿lens cut¿ observed during product evaluation could not be confirmed to be related to the manufacturing or design process.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.
Additional Manufacturer Narrative
Additional information: the following additional modulation transfer function (mtf) measurements were performed by johnson & johnson manufacturing site: the complaint lens half was evaluated by manufacturing site for optical assessment.Lens power and through-focus mtf measurements were performed.The lens power passed, confirming that the lens has the correct lens power.Through-focus mtf optical quality showed the typical shape of tecnis odyssey lens and showed slightly better simulated visual acuity.Any difference can be attributed to the lens being cut into two pieces and only half of the lens was measured.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: 22778960
• Report Number: 3012236936-2025-000215
• Device Sequence Number: 15849365
• Product Code: MFK
• UDI-Device Identifier: 05050474810778
• UDI-Public: (01)05050474810778(17)270521
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2025

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
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 08/25/2025; 10/14/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/16/2025; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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 Age: 53 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White