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	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3, a4, and a5: unknown, as information was requested but not provided.Section d6b - explant date: not applicable, as lens remains implanted.Section e1 - email address: unknown, as information was requested but not provided.Section e1 - telephone number: (b)(6).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 this review, if there is any further relevant information a supplemental medwatch will be filed.An attempt has been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that when the physician used the preloaded toric intraocular lens (iol) which was set up by the assistant as usual, the physician felt resistance when turning the plunger.Since there was no replacement device, the iol was implanted.After cleaning the iol during irrigation and aspiration, it was noticed that the optic was damaged.Account indicated that the iol was set with balanced salt solution (bss) and the assistant executed the set up until the plunger was first turned.One week after surgery, the patient did not have any particular problems or dissatisfaction, so the iol was not replaced.No patient injury was reported.No other medical intervention was required.Through follow-up, we learned that the bss used was from a competitor and it was used at room temperature.The instructions for use were followed.No further information was provided.
Additional Manufacturer Narrative
Additional information: section h3 - device evaluated by manufacturer? yes.Photographs provided by the customer were evaluated.The photographs showed a scratch like mark located paracentral to the optical center of the iol with an approximate length of 0.3-0.4 mm.Per the location of the mark, it is possible for the incident to impact patient¿s quality of vision in the event the lens remains implanted; however, the actual clinical impact as well as the potential root cause could not be determined from a picture.The complaint issue "difficult to use¿ was not identified during photograph evaluation.The complaint issue "lens damaged" was not identified either.The observed "cosmetic issues" is similar to the reported complaint issue of lens damaged.However, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction were found.All pertinent information available to johnson and 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: 22448611
• Report Number: 3012236936-2025-000175
• Device Sequence Number: 8597774
• Product Code: MFK
• UDI-Device Identifier: 05050474811065
• UDI-Public: (01)05050474811065(17)270806
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 10/23/2025

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: DRT1500055
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2024
• 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