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

Model Number	DCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Posterior Capsule Opacification (4807)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4: weight: unknown/not provided.Section d6b: if explanted, give date: not applicable, as the lens remains implanted.Section h3: the 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 will be filed.Section h6: health effect - impact code: 4625 - yag (yttrium aluminum garnet).An attempt was made to obtain the missing information; however, no additional information was available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after the preloaded monofocal intraocular lenses (iols) were implanted in the right (od) and left eye (os), the patient developed posterior capsule opacification (pco) in both eyes.The issue for both eyes was first noted during a subject visit.The pco was resolved with a yttrium aluminum garnet (yag) capsulotomy procedure on (b)(6) 2025 os, and on (b)(6) 2025 od.There were no additional medical or surgical intervention reported.The patient's pre-operative best spectacle corrected visual acuity (bscva) was recorded as 30 os and 20 od, and post-operative bscva improved to 20 for both eyes.No limitations in activities of daily living were reported by the patient.Directions for use were followed.The patient has fully recovered in both eyes.No further information was provided.This report is to capture the event for the od.A separate report will be submitted to capture the event for the os.
Additional Manufacturer Narrative
Additional information and corrected data: additional information was received which provided the initial reporter¿s correct email address.Upon further review, it was noticed that the initial mdr reported that the pre and post operative best corrected distance visual acuity bcdva was 20 and 20 for the right eye, but should have stated 20/20 and 20/20.It was also noted that the report source of ¿study¿ was not selected for section g2 on the initial mdr.Therefore, this supplemental mdr is capturing this information.The following fields have been updated accordingly: section e1: email address: (b)(6) section g2: report source (check all that apply): study.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: 23796928
• Report Number: 3012236936-2025-000335
• Device Sequence Number: 5712968
• Product Code: HQL
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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 Expiration Date: 01/20/2026
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000210
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2023
• 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: 69 YR
• Patient Sex: Female
• Patient Race: White