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

Model Number	DRT150
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Ejection Problem (4009); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Choroidal Hemorrhage (4810)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d6b, if explanted, give date: not applicable.The lens remains implanted.Therefore, it was not explanted.Section h3, device evaluated by manufacturer: the device was not returned for evaluation as it remains implanted.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.Section h6- health effect - impact code: 4625 used to capture the surgical intervention/maneuver required to unstick the lens.Attempts have been made to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded johnson and johnson (jnj) intraocular lens (iol) had super sticky haptics and were hard to come apart.When the iol came out the surgeon reported that the lens jumped out, it bumped the iris and caused a little bit of bleeding in the eye which he eventually achieved hemostasis and the bleeding stopped.The lens unfolded correctly after the haptics were pulled apart.Unsure if the haptics were stuck to each other or the optic.No further information was provided.
Additional Manufacturer Narrative
Through follow-up the customer provided additional details.This current report is to provide this information.The customer first reported the explant to johnson and johnson personnel on the day of the explant (b)(6) 2025.The operative eye is the left eye.The doctor stated this is an "iol malfunction".The customer confirmed there was no patient injury.And the suspect product was discarded therefore it will not be returned.Section a2 age or date of birth: (b)(6) 1960.Section a3b, gender: the customer said ¿female¿.Section d6b, if explanted, give date: (b)(6) 2025.Section h6- health effect - impact code: 4629 used to capture the explant procedure.Section h6-type of investigation: code 4115 to indicate the suspect product was discarded.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: 20720454
• Report Number: 3012236936-2024-000302
• Device Sequence Number: 14381306
• Product Code: MFK
• UDI-Device Identifier: 05050474811393
• UDI-Public: (01)05050474811393(17)270522
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRT150
• Device Catalogue Number: DRT1500220
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 02/05/2025; 12/15/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 02/13/2025; 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female