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

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	12/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a4, a5 patient information: customer indicated patient information cannot be provided due to personal data privacy legislation/policy.Section h3-other (81): the device was not returned for evaluation as it was discarded.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.Attempt was made to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.".
Event or Problem Description
It was reported that the johnson and johnson (jnj) intraocular lens (iol) was explanted from the patient's left eye due to the patient experiencing hyperopic outcome.The visual issues were first observed during a post-op exam.Symptoms lasted about 2 months.Reportedly, the directions for use were followed.The iol was replaced with another jnj lens of the same model zlb00 but 22.5 diopter.There were no complications such as incision enlargement, vitrectomy, sutures or delay in procedure.Medication outside the standard of care was not prescribed.The patient¿s daily activities were not impacted by this event.Patient has fully recovered.No further information was provided.

• 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: 18938335
• Report Number: 3012236936-2024-00694
• Device Sequence Number: 6886771
• Product Code: MFK
• UDI-Device Identifier: 05050474560710
• UDI-Public: (01)05050474560710(17)261209
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0220
• Was Device Available for Evaluation?: No
• 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: 03/13/2024
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2022
• 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: Unknown