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); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6, patient information: the customer declined to provide since the product did not contact the eye and due to patient privacy.Section d6a, if implanted, give date: not applicable as the device did not contact the patient.Section d6b, if explanted, give date: not applicable as the device did not contact the patient, therefore not explanted.Section h3, device evaluated by manufacturer: 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.Attempts were made to obtain the missing information.However, it was not provided.All pertinent information available to johnson & johnson surgical vision.
Event or Problem Description
It was reported that the leading haptic on the preloaded johnson and johnson (jnj) intraocular lens (iol) was inverted and excessive resistance was felt when advancing the iol.The doctor noticed the inverted haptic under a microscope.There was no contact with the preloaded device or iol.The procedure was completed with a backup lens.There were no complications such as a capsule tear, vitrectomy or sutures.Reportedly, the directions for use were followed.The patient is doing well.
Additional Manufacturer Narrative
Additional information.Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: aug 19, 2025.Section h3: evaluated by manufacturer? yes.Device evaluation: the complaint product was received.The product was visually inspected under magnification revealing that a portion of torn lens was inside the cartridge tip.The cartridge tip was observed to be damaged.Ophthalmic viscosurgical device (ovd) was observed inside the cartridge.The plunger rod, lens module, and handpiece were inspected, and no issues were identified.The lens was also visually inspected revealing that the lens was torn with one haptic detached, and coated in viscoelastic residue.The lens was cleaned and inspected and no further issues were identified.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.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: 22581056
• Report Number: 3012236936-2025-000201
• Device Sequence Number: 7232858
• Product Code: MFK
• UDI-Device Identifier: 05050474811300
• UDI-Public: (01)05050474811300(17)270731
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• 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: DRT1500175
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 08/28/2025; 12/15/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 09/04/2025; 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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: Unknown