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

Model Number	DRT150
Medical Device Problem Codes	Scratched Material (3020); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the preloaded multifocal intraocular lens (iol), model drt150, was implanted into the patient¿s left eye and subsequently explanted during the same surgery due to a scratched lens and haptics that were stuck together, as shown in the attached photos.Additional information confirmed that the procedure was successfully completed using a back-up lens of the same model and diopter.The patient is reported to be doing well.No further information was provided.
Additional Manufacturer Narrative
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.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.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes section d9: returned to manufacturer on: february 24, 2026 section h3: device evaluated by manufacturer: yes device evaluation: visual inspection under magnification was performed on the suspect product and found the lens was visually inspected revealing that the lens was cut in half with a scratch on the optic of the lens.No further issues were identified.The customer provided photos were evaluated and shows an eye implanted with the suspected complaint lens and the haptics could be observed to be stuck together.The optic was observed to have scratch like marks.No further evaluation was performed.The complaint issue "cosmetic issues" and "haptic stuck to haptic" were identified during product and photo evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: based on the complaint investigation results, no product deficiency or product malfunction could be identified.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: 24536304
• Report Number: 3012236936-2026-000060
• Device Sequence Number: 15710068
• Product Code: MFK
• UDI-Device Identifier: 05050474811386
• UDI-Public: (01)05050474811386(17)280606
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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: DRT1500215
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2025
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 89 KG