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

Model Number	DRT225
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a4, a5, a6: unknown/ not applicable since no patient contact.Section d6a: if implanted, give date: not applicable, as no indication that lens was implanted.Section d6b: if explanted, give date: not applicable, as no indication that lens was implanted, hence not explanted.Section h3- no: 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, complaint trending, and risk documentation 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 an intraocular lens (iol) toric was damaged in the preloaded injector and it was not implanted.The surgery tech (very experienced tech) told the surgeon that the plunger would not advance and she didn't want to put any more force on it.The surgeon inspected it under the scope but could not see why it would not advance.As the customer only order one lens and no backup, before leaving the patient aphakic, and the surgeon hoped that he could salvage the iol and load it manually.The surgeon then cut through the injector plastic behind the lens.Once the surgeon had a small window to see the lens, he could see that one of the haptics had broken off, therefore he knew that he could not salvage the iol.Regardless, the surgeon left the patient aphakic.It was noted that there was no patient contact with the product and that a secondary iol placement will occur when iol arrives.No other information was provided.
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: 20163563
• Report Number: 3012236936-2024-000245
• Device Sequence Number: 15282018
• Product Code: MFK
• UDI-Device Identifier: 05050474811935
• UDI-Public: (01)05050474811935(17)270620
• Combination Product (Y/N): N
• Initial Reporter State: GU
• 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
• Report Date (Section B): 01/08/2026

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: DRT2250195
• 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: 09/03/2024
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2024
• 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: Male