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

Model Number	ZLU225
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the zlu225 model intraocular lens (iol) front haptic was incorrectly positioned as the surgeon started to place the lens.The surgeon stopped and pulled away from the patient, lens was still in cartridge, and there was patient contact.It was noted the cartridge was split and leading haptic had gone through the cartridge.Through follow-up, additional information was received confirming the 1mtec30 cartridge tip was cracked and the haptic was also damaged.The procedure was completed using another iol same model and diopter.There was no patient injury, no medical intervention, and no surgical intervention.Patient status post-procedure was reported as doing well.No further information is available.This report captured the haptic damage issue.A separate report captures the cartridge tip damage issue.
Additional Manufacturer Narrative
Additional information: section a-5 patient ethnicity: a-5 patient ethnicity.Section d-6a date implanted: not applicable as the iol was not implanted.Section d-6b date explanted: not applicable as the iol was not implanted, therefore not explanted.Section h3-81: the iol 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: 12-sep-2023 section h-3: device evaluated by manufacturer: yes device evaluation: the complaint lens was received inside of the original lens case.Visual inspection under magnification revealed that the lens was received crushed in the lens insert.The lens was cleaned and, damaged consistent with being crushed could be identified.No haptic damage was identified.Complaint issue "dc-haptic damaged" was not confirmed during product evaluation.However, based on the complaint investigation results, the observed issues during product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the complaint investigation results, the product was released within specifications.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.

• 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: 17477292
• Report Number: 3012236936-2023-02047
• Device Sequence Number: 2773369
• Product Code: MFK
• UDI-Device Identifier: 05050474689923
• UDI-Public: (01)05050474689923(17)250609
• 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
• Report Date (Section B): 10/09/2023

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: 06/09/2025
• Device Model Number: ZLU225
• Device Catalogue Number: ZLU225U185
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2020
• 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: Female
• Patient Weight: 64 KG
• Patient Race: White