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

Model Number	DRT300
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the preloaded multifocal toric intraocular lens (iol) exhibits signs of scratching.Additional information noted device has been opened and not used.It is unknown whether the tip of the cartridge was damaged, whether additional resistance was encountered during lens delivery, or whether the cartridge contacted the eye.The specific location of the lens scratch could not be confirmed, and it is unknown whether the optic or haptic was damaged.The extent of patient contact is also unknown; however, it was noted that the lens was not implanted.The procedure was completed using a backup lens, (the serial number of the replacement lens is unknown).No patient injury was reported, and no unplanned medical or surgical interventions, such as vitrectomy, incision enlargement, or sutures, were required.It is unknown whether the device caused or contributed to the reported event, and the current patient outcome remains unknown.No further information was provided.
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5 and a6: unknown, information was requested but not provided.Section d6a: if implanted, give date: not applicable, the lens was not implanted.Section d6b: if explanted, give date: not applicable, the lens was not implanted.Hence, not explanted.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 missing information; however, the information was not available.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: returned to manufacturer on: mar 31, 2026.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection revealed that the cartridge was cut and the plunger rod was bent.The cartridge tip was also deformed; this damage is consistent with the cartridge being cut and manipulated in order to remove the lens.The lens module and handpiece were inspected; no further issues were identified.The lens was coated in viscoelastic residue.The lens was cleaned and inspected; scratches and damage was observed on the surface and edge of the lens.The complaint issue of cosmetic appearance was identified during product evaluation; however, based on the investigation results, it could not be confirmed to be related to a manufacturing or design issue.No other observed findings were confirmed to be associated with a manufacturing or design cause.Conclusion: based on the investigation, no malfunction or product deficiency was 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: 24635327
• Report Number: 3012236936-2026-000070
• Device Sequence Number: 15666709
• Product Code: MFK
• UDI-Device Identifier: 05050474812604
• UDI-Public: (01)05050474812604(17)280211
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/24/2026

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: DRT300
• Device Catalogue Number: DRT3000235
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• 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