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

Model Number	DRT375
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h3: the device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the lens was explanted due to visual outcomes that did not meet the expected standards, leading to patient dissatisfaction.The lens was explanted during a secondary surgical procedure with an unknown intraocular lens.No further information is available.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: (b)(6) 2025.Section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification was performed on the suspect product and found the lens was cut in half with one haptic detached.The lens was cleaned and damaged on the edge of the lens, and damage on the detached haptic was observed.No further evaluation was performed.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The other issues observed during the product evaluation could not be confirmed to be related to the manufacturing or design process.Based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that section g4: pma/510(k) number in the initial mdr was inadvertently submitted missing the ¿p¿ before the numerical value.The complete number is p980040.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: 22561496
• Report Number: 3012236936-2025-000188
• Device Sequence Number: 19838886
• Product Code: MFK
• UDI-Device Identifier: 05050474813045
• UDI-Public: (01)05050474813045(17)270619
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2026

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: DRT375
• Device Catalogue Number: DRT3750160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 08/19/2025; 12/15/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 09/09/2025; 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• 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: 75 YR
• Patient Sex: Female