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

Model Number	DRT150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Corneal Edema (1791); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a preloaded multifocal intraocular lens (iol), model drt150, could not be implanted.The nurse observed a crack in the lens periphery, and the lens was explanted.Additional information confirmed that the optic was damaged.The cartridge and lens made contact with the patient¿s right eye during the process.The original lens was explanted and replaced with a backup lens of the same model and diopter.The procedure was completed successfully.No patient injury was reported; however, the patient experienced a longer recovery period due to the need for lens explantation, including corneal edema which resolved approximately 14 days post-procedure.No vitrectomy or sutures were required, though the incision was mildly enlarged to accommodate the explant.The device was determined to have caused or contributed to the event.The patient¿s current outcome is stable, with 20/25 uncorrected distance visual acuity and jaeger 1+ near acuity at two weeks post-operative.The complaint device was discarded.No additional information was provided.
Additional Manufacturer Narrative
Section a4: weight: 104.5 kg.As the system does not support entries with decimal points, the weight could not be populated in that section.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same surgery.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.Section h6: health effect- impact code 4625-hs-incision enlarged: procedural complications section h6: health effect- impact code 4631-pt-removal and replacement: procedural complications.Section h6: health effect- clinical code 4581-hs-incision enlarged: procedural complications.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.

• 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: 24224014
• Report Number: 3012236936-2026-000030
• Device Sequence Number: 9366974
• Product Code: MFK
• UDI-Device Identifier: 05050474811218
• UDI-Public: (01)05050474811218(17)280129
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRT150
• Device Catalogue Number: DRT1500130
• 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: 01/05/2026
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2025
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White