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

Model Number	DRT150
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that the intraocular lens had the injector cracked.It was noted when inserting.During the same procedure, another j&j lens with the same model and diopter was implanted.The patient¿s outcome is unknown.No injury or medical intervention was required.No further information was provided.
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section e1: email not provided section h3: the device was received and is pending investigation at the time of this report.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the investigation, 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.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: aug 05,2024.Section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection of the complaint device reveal that it presented with the plunger rod fully advanced.Viscoelastic residue was distributed through the entire length of the cartridge.The cartridge presented with a crack/damage in the tube of the cartridge with the damage extending to the cartridge tip.The lens module was inspected, presenting with no viscoelastic residue or damage.Device assembly was inspected and no issues were identified.The plunger rod advancement was inspected and no resistance was felt.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order was performed.Conclusion: the complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: the initial submission inadvertently reported data in the patient sections a2 and a3.The fields should have stated unknown.This current report captures the corrected information below.Section a2.Age/date of birth: unknown/not provided section a3.Gender: unknown/not provided 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: 19958288
• Report Number: 3012236936-2024-000223
• Device Sequence Number: 7137047
• Product Code: MFK
• UDI-Device Identifier: 05050474811348
• UDI-Public: (01)05050474811348(17)261013
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,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
• Device Model Number: DRT150
• Device Catalogue Number: DRT1500195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2024
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 08/21/2024; 09/10/2024; 12/15/2025
• Initial Report FDA Received Date: 08/11/2024
• Supplement Report FDA Received Date: 09/13/2024; 09/25/2024; 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2023
• 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: 63 YR
• Patient Sex: Female