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	Visual Disturbances (2140)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: at the time of the investigation, device was not available for evaluation, therefore no testing could be performed.The reported event cannot be confirmed.Manufacturing record review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: based on the investigation results there is no indication of a product quality deficiency.Section h6: health effect- impact code 4619: temporary impairment (hm-visual disturbance- dysphotopsia- requiring surgical intervention: dysphotopsia - (requiring surgical or medical intervention) 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.
Event or Problem Description
It was reported that a patient underwent bilateral implantation of preloaded monofocal intraocular lenses (iols).Postoperatively, the patient experienced poor adaptation to blended vision, and the iols were explanted during a secondary surgical procedure on the same day.No incision enlargement, sutures, vitrectomy, or procedural delay were reported.The patient¿s condition was temporarily impaired, with an impact on activities of daily living, such as reading.Best-corrected visual acuity was 20/20 in both eyes preoperatively and postoperatively.The directions for use were followed, and no additional medical attention or medications outside the standard of care were required.No further information was provided.This report pertains to patient's right eye.A separate report will be submitted for the patient's left eye.
Additional Manufacturer Narrative
Additional information received: additional information received confirmed that the replacement lens used was non¿johnson & johnson lens.The patient was reported to be happy following the replacements.Information regarding post-operative refraction with the replacement lens is not yet available.Corrected data: upon further review it was noticed that the following fields were inadvertently not included in the initial medwatch report.The following section have been updated accordingly: section h6: type of investigation: 4109-historical data analysis.Section h6: type of investigation: 3331-analysis of production records.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: 25035342
• Report Number: 3012236936-2026-000114
• Device Sequence Number: 9140338
• Product Code: HQL
• UDI-Device Identifier: 05050474636088
• UDI-Public: (01)05050474636088(17)280429
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted 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): 06/22/2026

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: DCB00
• Device Catalogue Number: DCB0000200
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 05/04/2026; 05/28/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/27/2026; 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2025
• 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: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White