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	Visual Disturbances (2140); Halo (2227)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4: weight: unknown/not provided.Section a5: ethnicity: unknown/not provided.Section a6: race: unknown/not provided.Section d6a.If implanted, give date: unknown, information not provided.Section d6b.If explanted, give date: unknown, information 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 the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient experienced dysphotopsia symptoms after the implantation of a preloaded extended depth of focus intraocular lens (iol) in the right eye.The visual symptoms were described as halos and glare.The original lens was subsequently explanted during a secondary surgery.There were no reported patient harm.The device was discarded and not available to return.No further information was provided.
Additional Manufacturer Narrative
The following fields were updated accordingly: section d6a: if implanted, give date: (b)(6) , 2026 section e1: title (e.G., mr., ms.): dr.Section e1: first/given name: (b)(6) section e1: last name: (b)(6) section e2: health professional?: yes section e2: occupation: physician attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information was received regarding the patient¿s pre-operative measurements.It was noted that the patient¿s daily activities were affected, as they were unable to see clearly at a distance and were under-corrected.The pre-operative and post-operative refractions were -1.25 +0.25 × 150 and -0.50, respectively.The pre-operative best spectacle-corrected visual acuity (bscva) was 20/20, while the post-operative best spectacle visual acuity (bsva) was 20/25.The intended target refraction was plano.The patient did not have any pre-existing conditions that could have affected the iol calculation.No unplanned surgical interventions such as incision enlargement, sutures, or vitrectomy were required.Information regarding medications prescribed outside the standard of care was not available.No further information was provided.The following fields were updated accordingly: section a4: weight: 100 pounds section a5: ethnicity: not hispanic/latino section a6: race: white section h6: impact code(4619): blurry vision (impacting daily life) 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: 24415283
• Report Number: 3012236936-2026-000049
• Device Sequence Number: 20303388
• Product Code: HQL
• UDI-Device Identifier: 05050474761780
• UDI-Public: (01)05050474761780(17)270430
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2026

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: DXR00V
• Device Catalogue Number: DXR00VU195
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 02/24/2026; 03/26/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/19/2026; 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 45 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White