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

Model Number	ZKB00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a multifocal intraocular lens (iol) was explanted from the patient's right eye due to lens dislocation.Another johnson & johnson lens of the same model, but different diopter (20.5d) was used as a replacement iol.No surgical and/or medical interventions required.There was no patient injury reported.The patient outcome is unknown.No further information was provided.
Additional Manufacturer Narrative
Section a4 and a5: unknown/ asked but not available.Section h3-other (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.Section h6: health effect - clinical code: 4581 - this code was used for the reported lens dislocation.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.Returned to manufacturer on: feb 5, 2024.Section h3.Device evaluated manufacturer? yes.Device evaluation: the complaint lens was received in a plastic bag stuck to medical foam.The lens was visually inspected under magnification revealing that the lens was cut in half.The lens was further inspected an no issues that could cause or contribute to the complaint issue was observed.The complaint issue "instability of device after implantation" was not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the investigation, no malfunction or product deficiency was identified.Corrected data: in review, it was noticed that the following text "javascript:void(window.Setcalendarday(18, 'cell_18'));" was inadvertently added to the section "b7" of the initial mdr report in error.This information is unrelated/does not apply to this event which should not have been entered and this supplemental mdr report is to correct that.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: 18540070
• Report Number: 3012236936-2024-00133
• Device Sequence Number: 18074345
• Product Code: MFK
• UDI-Device Identifier: 05050474560079
• UDI-Public: (01)05050474560079(17)270125
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 02/20/2024

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: ZKB00
• Device Catalogue Number: ZKB00U0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/27/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female