MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS ODYSSEY TORIC II IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DRT300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: male section a-4 patient weight: unknown/asked information was not provided.Section h-3 device evaluated by manufacturer: the complaint 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 the review, if there is any further relevant information a supplemental medwatch report will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The drt300 model intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye).Due to complaints of glare, the iol was explanted in a secondary surgical procedure and replaced with a diu300 18.5 iol.There was no incision enlargement, no serious patient injury, and no vitrectomy during the iol explant procedure however, unplanned sutures were required.The sutures were used for prophylactic measures.Patient prognosis post-lens exchange was reported as good and visual acuity was 20/25.No further information is available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes section d9: returned to manufacturer on: apr 15, 2026 section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection revealed that the suspect intraocular lens (iol) was received cut in half.The lens was cleaned and marks were found on the lens surface.The physical characteristics of the lens matched a drt model lens.No other issues were identified and no further evaluation was performed.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the investigation, no malfunction or product deficiency was identified.Corrected data: upon review, it was identified that an incorrect code (213) was entered in section h6 (investigation findings) instead of the appropriate code (3221).This supplemental mdr is to correct that information.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: TECNIS ODYSSEY TORIC II IOL
• 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: 24787149
• Report Number: 3012236936-2026-000086
• Device Sequence Number: 9889100
• Product Code: MFK
• UDI-Device Identifier: 05050474812499
• UDI-Public: (01)05050474812499(17)280212
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2026
• 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): 05/28/2026

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: DRT300
• Device Catalogue Number: DRT3000180
• 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: 03/18/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/05/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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: 81 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White