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

Model Number	DRT150
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) was defective as the focal point of the optic of the lens was torn.The lens was removed and replaced with another lens in the same procedure.No other information is available.
Additional Manufacturer Narrative
Section a3b and a4: unknown/ asked but not available.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: contact's name, email address and phone number: unknown/ asked but not available.Section h3: the device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information; however, to date, no response has been received.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: 5/6/2025.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification was performed on the suspect product and found the plunger rod was fully advanced.Viscoelastic residue was observed to be evenly distributed throughout the cartridge; stress marks were observed on the cartridge tip but were in specification for a used device.No cartridge or cartridge tip issues were observed.The lens module was inspected revealing no issues or viscoelastic residue.Device assembly was inspected revealing no issues; viscoelastic residue was observed below the lens module indicating an excessive amount of ovd may have been used which could contribute to the complaint issue reported.Plunger rod advancement was inspected revealing no issues; however, the plunger rod tip was observed to be bent.No lens was received for evaluation and no further evaluation was performed.Conclusion: the complaint issue "iol torn" was not identified during product evaluation as no lens was received for evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Based on the complaint investigation results, the product was released within specifications.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: 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.The following field was updated accordingly: section g4: pma/510(k) number: 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: 21939755
• Report Number: 3012236936-2025-000118
• Device Sequence Number: 20962009
• Product Code: MFK
• UDI-Device Identifier: 05050474811416
• UDI-Public: (01)05050474811416(17)270927
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,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
• Operator of Device: Health Professional
• Device Model Number: DRT150
• Device Catalogue Number: DRT1500230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 05/15/2025; 12/15/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/09/2025; 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Race: White