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); Visual Disturbances (2140)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: male section h-3 device evaluated by manufacturer: the complaint 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 report will be filed.Section h-6 health effect - impact code: 4619 ¿ glare and visual disturbance - dysphotopsia section h-6 health effect - clinical code: 2140 ¿ glare and visual disturbance - dysphotopsia attempts were made to contact the customer account requesting additional information regarding complaint 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
The drt150 model intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye).Due to patient complaints of difficulty with glare and blurred vision while driving at night, and difficulty with reading, the iol was explanted in a secondary surgical procedure; replacement iol information is unknown.There are no daily activities that the patient cannot perform that he was able to prior to the surgery.There was no incision enlargement, no medical attention, no medication prescribed (outside of standard care), no procedural delays, no suture(s), and no vitrectomy during the lens exchange procedure.Patient prognosis post lens exchange was reported as fully recovered.The iol directions for use were followed.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 (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 06-jan-2026.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received inside a sealed non-j&j pouch labelled with a patient sticker.During a visual inspection, the device was inspected under magnification.The lens was received coated in viscoelastic residue and stuck to a piece of paper.The lens removed and cleaned revealing no issues that could cause or contribute to the complaint issue.The physical characteristics of the received lens was confirmed to match that of a drt150 model lens.No further evaluation was performed.The complaint issues reported could not be confirmed during product evaluation, and no issues were identified.The manufacturing records for the product were reviewed; the units were released in accordance with specifications.The lens diopter results obtained from the miq electronic system show that this po was released within diopter specifications.A search revealed that no other complaints have been received for this production order (po) number.Conclusion: based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction was identified.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: 23733537
• Report Number: 3012236936-2025-000324
• Device Sequence Number: 21260265
• Product Code: MFK
• UDI-Device Identifier: 05050474811317
• UDI-Public: (01)05050474811317(17)270808
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 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,Followup
• Report Date (Section B): 01/16/2026

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: DRT1500180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 01/07/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/08/2026; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White