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

Model Number	DRT150
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: date of event: unknown, not provided, but the best estimate date is after the lens implantation on (b)(6) 2024.Section d6b: if explanted, give date: not applicable, remains implanted in the eye.Section h3: other 81: the device was not returned for evaluation as the lens remain implanted in the eye.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device 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 - clinical code: 2137- blurred vision- used to indicate blurred vision and poor near vision section h6: health effect - impact code: 4644 - medication required - used to indicate topical steroids treatment and non-steroidal anti-inflammatory medication.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient who underwent the first eye surgery with a tecnis odyssey toric simplicity intraocular lens (iol) is not receiving the expected near vision post-operation.The patient's visual acuity measurements were provided as distance vision (dv): 20/20, pinhole (ph): 20/25 -2, near vision (nv): j8, manifest refraction (mr) +0.25 +0.50 x021 20/25 -1, and add +2.00 j1+.Patient stated his distance visual acuity seems pretty good but experienced intermittent hazy vision in the operated eye (os) and struggles with near vision tasks, he cannot see his computer with his left eye.No pain or discomfort has been reported, and the patient has not been using tear drops.Non-steroidal anti-inflammatory drugs (nsaid) and steroid drops are scheduled as part of the medical intervention.The second eye surgery for right is planned for on (b)(6) 2025.The possibility of explanting the left lens is being considered.No further information is available.
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: 21756279
• Report Number: 3012236936-2025-000090
• Device Sequence Number: 18180855
• Product Code: MFK
• UDI-Device Identifier: 05050474811263
• UDI-Public: (01)05050474811263(17)260818
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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 Expiration Date: 08/18/2026
• Device Model Number: DRT150
• Device Catalogue Number: DRT1500155
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2023
• 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: Other; Required Intervention
• Patient Sex: Male