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

Model Number	DRT225
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the johnson and johnson (jnj) intraocular lens (iol) was cracked.The iol was partially inserted and then removed because multiple cracks were noticed on the optic.The procedure was successfully completed with a replacement iol of the same model and diopter.There was no patient injury, no vitrectomy, sutures and incision enlargement.Reportedly, the patient is doing well.No further information was provided.
Additional Manufacturer Narrative
Correction: the initial report should have included the following information.Section h11 should have been check marked and should have included an explanation for section h3, device evaluation.This current report provides the correction below.Section h3, device evaluated by manufacturer: no.The device has not been returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record 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 h11, additional narrative/data: manufacturer narrative.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: date returned to manufacturer: sep 29, 2025.Section h3: evaluated by manufacturer? yes.Device evaluation: the complaint product was received.Product was visually inspected revealing that the cartridge tip was damaged and the cartridge tip was cracked.The plunger rod was also observed to be damaged.The lens module and handpiece were inspected, and no issues were identified.The lens was visually inspected and observed to be cut in half and coated in viscoelastic residue and dried blood.The lens was cleaned and inspected and damaged on the surface and edge of the lens was observed.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.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.Section g4: pma/510(k) number: 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: 22881327
• Report Number: 3012236936-2025-000225
• Device Sequence Number: 9293937
• Product Code: MFK
• UDI-Device Identifier: 05050474811928
• UDI-Public: (01)05050474811928(17)271118
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: DRT225
• Device Catalogue Number: DRT2250190
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 08/23/2025; 10/17/2025; 12/15/2025
• Initial Report FDA Received Date: 08/23/2025
• Supplement Report FDA Received Date: 08/24/2025; 10/20/2025; 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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 Age: 65 YR
• Patient Sex: Male