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

Model Number	DRT375
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
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.
Additional Manufacturer Narrative
Section a6: race: unknown/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.An attempt was made to obtain the missing information; however, the information was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after the preloaded multifocal toric intraocular lens (iol) was implanted in the right eye, the patient still needed to use reading glasses for computer work, reading, and phone use.The issue was first identified during a post-operative examination.The patient's pre-operative (pre-op) refraction was 20/50-1 and pre-op best spectacle corrected visual acuity (bscva) was 20/25-2.The patient's post-operative (post-op) refraction for the original lens was 20/25-1 and post-op bscva for the original lens was 20/25.The intended target refraction was +0.05.The patient did not have a loss of 2 or more lines of bscva.The patient was over corrected.The patient did not have any pre-existing condition that affected calculation.The lens was subsequently explanted during a secondary surgery and replaced with a non-johnson and johnson iol (+17.5 diopter).There was no delay in procedure.The procedure did not involve unplanned incision enlargement, sutures, or vitrectomy.No additional medical attention was needed and no medication was prescribed that was outside the standard of care.There was no patient injury.The patient has fully recovered.The patient's post-operative refraction after the lens exchange was 20/25-1.It is unknown if the device caused or contributed to the event.No further information was provided.
Additional Manufacturer Narrative
The product was received for evaluation.Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jan 6, 2026.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection of the complaint device reveal that the lens was cut in half and coated in viscoelastic residue.The lens was cleaned and inspected, and no further issues were observed.The complaint issues were not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the complaint investigation results, the product was released within specifications.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: 23794857
• Report Number: 3012236936-2025-000331
• Device Sequence Number: 16068595
• Product Code: MFK
• UDI-Device Identifier: 05050474813069
• UDI-Public: (01)05050474813069(17)260926
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/03/2026

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: 09/26/2026
• Device Model Number: DRT375
• Device Catalogue Number: DRT3750170
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 01/21/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/09/2026; 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic