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

Model Number	DRT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following implantation of a preloaded multifocal intraocular lens (iol), model drt225, in the patient¿s left eye, the patient experienced blurry vision and poor night vision.The patient reported an inability to perform night-driving activities that she had been able to do prior to surgery.The lens was subsequently explanted during a secondary surgical procedure with a non¿johnson & johnson lens.No incision enlargement, vitrectomy, sutures, or procedural delays were required.The patient¿s best-corrected visual acuity remained 20/20 both pre- and post-operatively.Directions for use were confirmed to have been followed.Initially it was reported that preoperative refraction: -0.75 -0.75 × 65, target refraction: -0.07 and postoperative refraction: plano sphere.However, during a follow-up they reported that preoperative refraction: -1.25 +0.50 × 64, postoperative refraction: +1.00 -0.50 × 145 and target refraction: plano.Postoperative refraction with the new lens has not yet been measured.No further information was provided.
Additional Manufacturer Narrative
Section a4: unknown, information was requested but not provided.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.Section h6: health effect- impact code: 4619-hm-blurry vision (impacting daily life activities) : vision blurred (impacting patient daily life activities) an attempts has been made to obtain missing information; however, the information has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: february 3, 2026.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection revealed hat the lens was cut in half and coated in viscoelastic reside.The edge of the lens also had a chip.No further issues were identified.During the product evaluation it was confirmed that the physical characteristics of the lens matched a drt225 model lens.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the complaint investigation results, no product deficiency or product malfunction could be 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: 24283108
• Report Number: 3012236936-2026-000034
• Device Sequence Number: 18623719
• Product Code: MFK
• UDI-Device Identifier: 05050474811904
• UDI-Public: (01)05050474811904(17)260927
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/11/2026

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: 09/27/2026
• Device Model Number: DRT225
• Device Catalogue Number: DRT2250180
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White