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	Blurred Vision (2137)
Date of Event	05/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a3b, a4, a5 and a6: unknown, as information was requested but not provided.Section d6b - explant date: not applicable, as lens remains implanted.Section e1 - email address: unknown, as information was requested but not provided.Section e1 - telephone number: (b)(6).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 this review, if there is any further relevant information a supplemental medwatch will be filed.An attempt has been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was initially reported that the preloaded intraocular lens (iol) was implanted in the patient's right eye on (b)(6) 2025.Four days after surgery, the patient's distance vision was 0.6p (1.2×s+1.00d c-1.00da75) and near vision was 0.4.The patient is very satisfied with both distance and middle vision, but somewhat dissatisfied with near vision.A replacement is being considered, depending on future test results.No patient injury was reported, and no other medical intervention was required.Through follow-up, we learned that a lens explant was attempted; however, the lens was left implanted because adhesion between the haptics and the posterior capsule had begun, and the zonule was notably weak.The account indicated that if the lens replacement procedure continued any longer, there was a risk of the iol dislodging.Consequently, the haptic that had been removed from one side was returned to the bag, resulting in the discontinuation of the replacement operation.After the procedure, the patient was prescribed with diquas, an ophthalmic solution to treat dry eyes and after some days, the patient seemed to be able to read small letters.No further information was provided.

• 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: 22503336
• Report Number: 3012236936-2025-000174
• Device Sequence Number: 9303255
• Product Code: MFK
• UDI-Device Identifier: 05050474813106
• UDI-Public: (01)05050474813106(17)280127
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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: DRT3750190
• 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: 06/02/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2025
• 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 Sex: Male