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

Model Number	ZKU225
Medical Device Problem Codes	Break (1069); Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the zku225 model intraocular lens (iol) was received in a sealed lens box with no damage and no transit damage.When carton was opened the cassette seal appeared questionable and account was concerned sterility may have been compromised.Through follow-up, additional information was received stating the product was opened upon receiving in shipment and it never made it to any procedure or anywhere near an operating room (or); therefore no patient contact.The exterior shipping box was in pristine condition however, when opening the shipping box and taking the cartridge out, the seal on the cartridge was already cut into and cartridge was damaged.No further information is available.
Additional Manufacturer Narrative
Additional information: sections a-2 patient age and date of birth, a-4 patient weight, and a-5 patient ethnicity and race: not applicable as there was no patient contact with the device.Section b-3: date of event: unknown/asked information unavailable.Section d-6a date implanted: not applicable as there was no patient contact with the device.Section d-6b date explanted: not applicable as there was no patient contact with the device, therefore not explanted.Section h3-81: 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, 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.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: 17-oct-2023.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the complaint sterilization pouches were received inside of the original folding carton.Visual inspection under magnification revealed that the complaint lens was received inside of a sealed inner and outer pouch.The seals were inspected and, no damage to the seals that would indicate a sterilization issue were identified.Complaint issues could not be confirmed during product evaluation, and no issues were identified.Conclusion: based on the complaint investigation results, the product was released within specifications and the reported complaint issues could not be confirmed.No product deficiency or product malfunction was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 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: 17892720
• Report Number: 3012236936-2023-02568
• Device Sequence Number: 12609872
• Product Code: MFK
• UDI-Device Identifier: 05050474687493
• UDI-Public: (01)05050474687493(17)250401
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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 Expiration Date: 04/01/2025
• Device Model Number: ZKU225
• Device Catalogue Number: ZKU225U140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 10/08/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2020
• 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