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 Codes	Blurred Vision (2137); Eye Pain (4467); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	09/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4, patient weight: unknown/not provided.Section a5, ethnicity: unknown/not provided.Section a6, race: unknown/not provided.Section d6b, if explanted, give date: not applicable as the doctor has no plans to remove the device.Section h3, device evaluated by manufacturer: the device has not been returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the johnson and johnson (jnj) intraocular lens (iol) was implanted into the patient¿s left eye.The patient experienced toxic anterior segment syndrome (tass).The issue was identified during the follow-up examination.The iol remains implanted, and the doctor has no plans to remove it.There was no unplanned incision enlargement and no sutures.It is unknown if there was an unplanned vitrectomy.The directions for use were followed.The patient¿s post-operative visual acuity outcome is unknown.Reportedly, no other patients received this lens, and no other issues were reported in the operating room.The patient states that the eye is sore and painful.Vision is bad.The patient¿s visual outcome was reported as ¿currently being treated.¿ the following treatment was required for tass.Topical, systemic, and intraocular medication, no subconjunctival.Prescription and over the counter medication was required.The customer did not indicate if the medication was required to preclude permanent injury and dosages were not provided.No culture or pcr (polymerase chain reaction) was performed.The customer did not observe a pattern in their cases and on the day of surgery this patient was #1.There were no other similar incidents on the same surgical day.There was no other johnson and johnson product involved.Follow-up was performed but no further information was provided.
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.Section g4: pma/510(k) number: 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: 23327912
• Report Number: 3012236936-2025-000266
• Device Sequence Number: 10612392
• Product Code: MFK
• UDI-Device Identifier: 05050474811331
• UDI-Public: (01)05050474811331(17)280205
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: DRT150
• Device Catalogue Number: DRT1500190
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• 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 Age: 66 YR
• Patient Sex: Male