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

Model Number	DRT150
Medical Device Problem Codes	Break (1069); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A3b, a4, a5 and a6: unknown, information not provided.D6a: not applicable as the lens was not implanted.D6b: not applicable as the lens was not implanted; therefore, not explanted.E1: initial reporter: email address: unknown, information not provided.E1: initial reporter: telephone number: unknown, information not provided.H3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint history for production order for this device 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 the technician had difficulty preparing the preloaded toric intraocular lens as it was quite firm and resisted advancement more than usual.When the surgeon fully advanced the lens, it broke and was replaced during the same procedure with a backup lens of the same diopter.Additionally, there was difficulty in advancing the injector's plunger, and the lens came out of the inserter broken.There was no report of unplanned vitrectomy, incision enlargement, or sutures.The procedure was delayed by 2 minutes.Directions of use were followed.No other information was provided.
Additional Manufacturer Narrative
The product was returned to the manufacturing site for evaluation.Additional information: section d9: device available for evaluation? yes section d9: date returned to manufacturer: sep 2, 2025 section h3: evaluated by manufacturer: yes device evaluation: visual inspection under magnification was performed and found the plunger rod advanced with viscoelastic residue observed throughout the cartridge.No issues were identified with the cartridge, lens module, device assembly, and plunger rod advancement.The plunger rod tip was bent.The lens was received cut into pieces, coated in viscoelastic residue, and had a haptic detached.The lens pieces were cleaned revealing scratches and damage on the lens and.No further evaluation was performed.The complaint issue "lens damaged" was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.The complaint issue "difficult to use" could not be confirmed during product evaluation.Manufacturing record review: the manufacturing records review for this production order shows that the units were released within specification.No process deviations (dev), nonconformances (nc/nr), or capas were found as part of this manufacturing records review.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.
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.

• 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: 22853567
• Report Number: 3012236936-2025-000220
• Device Sequence Number: 18235848
• Product Code: MFK
• UDI-Device Identifier: 05050474811348
• UDI-Public: (01)05050474811348(17)271111
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRT150
• Device Catalogue Number: DRT1500195
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 09/26/2025; 12/15/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/21/2025; 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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
• Patient Sex: Female