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	10/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d6b: if explanted; give date: n/a (not applicable).The intraocular lens remains implanted.Section h3: the device was not returned for evaluation as it remains implanted; 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a preloaded multifocal toric intraocular lens (iol) was implanted in the patient¿s left eye, and a preloaded multifocal iol was implanted in the right eye.Postoperatively, the patient experienced blurry vision at both near and distance that did not improve with refraction.The patient stated that she used to be able to sit on her couch and read but is no longer able to do so after the surgery.She is unhappy with distance vision with her multifocal iols and has tried them for one year without success.Pre-operative refraction was: manifest refraction (mr) dry, right eye (od) -1.25 +0.75 020 and left eye (os) +0.50 +0.75 107.Post-operative refraction was d -1.00 +0.25 030 "fuzzy" 20/25 hand motion (hm) and os -0.50+1.00 180 "still blurry" 20/25 hm.Target was od - 0.39 and os: -0.20.No medication outside standard of care required.The lenses remain implanted to date and the explant has not been scheduled yet.No further information was provided.The patient had bilateral lens implantation.This report is for the patient's left eye.A separate report will be submitted for the right eye.
Additional Manufacturer Narrative
Additional information received: section b5: additional information received confirmed that both eyes were explanted, with explant procedures performed on (b)(6) 2026 and (b)(6) 2026.The replacement lenses implanted were non¿johnson & johnson lenses.There were no unplanned surgical interventions.No patient injury was reported.The patient outcome was reported as good status post explant.The complaint devices were discarded.The following fields were updated accordingly: section d6b: if explanted; give date: (b)(6), 2026.Section h6: type of investigation: 4115 - device discarded the following health impact code was added: section h6: health impact code: 4629- device revision and replacement.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: 23874415
• Report Number: 3012236936-2025-000336
• Device Sequence Number: 18759516
• Product Code: MFK
• 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
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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: DRT225
• Device Catalogue Number: DRT2250205
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2024
• 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: Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 115 LB
• Patient Race: White