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

Model Number	ZLU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown; requested but not provided.Date of event: unknown; requested but not provided.The best estimate date is between feb 15, 2023 and aug 30, 2023.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 and complaint history for production order for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.An attempt was made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the non-preloaded multifocal toric intraocular lens (iol) was explanted from the patient's operative eye due to dysphotopsia.The issue was identified during a post-operative exam.Symptoms persisted for 4-5 months.The patient was still able to perform daily activities.No sutures, incision enlargement, or vitrectomy was required.There was no delay in procedure.No medical attention was required and no medication was prescribed (outside of the standard of care).There was no patient injury.The patient is fully recovered.The device was discarded.No further information was provided.
Additional Manufacturer Narrative
Additional information: through follow-up, it was learned that the left eye was affected, the date the first symptoms was noticed was (b)(6) 2023, and the replacement lens was a diu150 model 15.5 diopter.The patient is a white female and date of birth is (b)(6) 1959.The following fields have been updated accordingly: section a2: date of birth: (b)(6) 1959.Section a3: gender: female.Section a5: race: white.Section b3: date of event: mar 30, 2023.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: 18620081
• Report Number: 3012236936-2024-00253
• Device Sequence Number: 7416616
• Product Code: MFK
• UDI-Device Identifier: 05050474689275
• UDI-Public: (01)05050474689275(17)250318
• 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: 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): 02/23/2024

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 Expiration Date: 03/18/2025
• Device Model Number: ZLU150
• Device Catalogue Number: ZLU150U150
• 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: 01/10/2024
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: White