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

Model Number	DXR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Flashers (1864); Visual Disturbances (2140); Halo (2227)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a preloaded multifocal intraocular lens (iol), model dxr00v, was implanted in the patient¿s left eye.Postoperatively, the patient experienced persistent halos and starbursts around lights at night.The symptoms impacted patient¿s daily activities such as night driving due to glare.Was unable to perform certain daily activities, specifically driving at night due to glare.The best spectacle corrected visual acuity (bscva) was 20/40 preoperatively and 20/15 postoperatively.The lens was explanted during a secondary procedure and replaced with a monofocal lens (dib00) of the same diopter as the original lens.Postoperative refraction with the replacement lens was 20/30.No incision enlargement, vitrectomy, sutures, or procedural delays occurred, and no medical attention or medication outside of the standard of care was required.The patient is permanently impaired.Directions for use were followed.The complaint device is not available for return, as it was removed in pieces using the phaco machine.No further information was provided.
Additional Manufacturer Narrative
Section a5 and a6: unknown, information was requested but not provided.Section h3: the device was not returned for evaluation as it was discarded; 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.Section h6: health effect - impact code: 4619 - visual disturbance - starburst - surgical intervention required; 4619 - halo vision- surgical intervention required; 4619 - glare surgical intervention required.An attempts has been made to obtain missing information; however, the information has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in review, it was noticed that the sentence "was unable to perform certain daily activities, specifically driving at night due to glare." was inadvertently duplicated in section b5 of the original mdr report.This supplemental mdr report is to correct that information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: INTRAOCULAR LENS
• 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: 23875283
• Report Number: 3012236936-2025-000339
• Device Sequence Number: 5546244
• Product Code: HQL
• UDI-Device Identifier: 05050474761605
• UDI-Public: (01)05050474761605(17)260719
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 12/23/2025

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 Expiration Date: 07/19/2026
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU105
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2023
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 68 KG