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

Model Number ZLU225

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2023

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 320710033
• Report Number: 3012236936-2023-02047
• Device Sequence Number: 1
• Product Code: MFK
• UDI-Device Identifier: 05050474689923
• UDI-Public: (01)05050474689923(17)250609
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White