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

Model Number	DRT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	06/06/2025
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 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient underwent implantation of a preloaded multifocal toric intraocular lens (iol) in the right eye.During a post-operative examination, the patient reported experiencing unclear vision.Subsequently, the lens was explanted during a secondary surgery and replaced with a non-johnson & johnson toric lens of the same diopter (19.5d).The procedure was completed without complications, including unplanned incision enlargement, sutures, vitrectomy, or procedural delays.The directions for use was followed, and no additional medical attention or medication beyond standard care was required.The patient has fully recovered.The patient¿s pre-operative best spectacle corrected visual acuity (bscva) was 20/25 and bscva post-operatively 20/20 -1.There was no patient injury.No further information was provided.
Additional Manufacturer Narrative
Additional information: additional information received indicated that the date of event was 6/6/2025.It was confirmed that there was no patient injury such as capsule tear.No further information was provided.Corrected data: in review, it was noticed that an incorrect date ((b)(6) 2025) was inadvertently entered in section "b3" of the initial mdr report.The information has been updated in this supplemental mdr report based on the additional information received.The following field was updated accordingly: section b3: date of event: 6/6/2025.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: 24533732
• Report Number: 3012236936-2026-000060
• Device Sequence Number: 9026999
• Product Code: MFK
• UDI-Device Identifier: 05050474811348
• UDI-Public: (01)05050474811348(17)270913
• 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
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 03/31/2026

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: DRT150
• Device Catalogue Number: DRT1500195
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2024
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White