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

Model Number	ZLU375
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d6b: if explanted, give date: not applicable, as lens remains implanted.Section h3: no: the device was not returned for evaluation, as lens remains implanted; 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.
Event or Problem Description
It was reported that doctor has issues with a toric lenses that has rotated multiple times in a patient.The initial intraocular lens (iol) rotated and was explanted.Then it was also reported that the toric replacement iol was implanted at 98 degrees, but this one also rotated a few days after it was implanted in the patient's left eye.Day #1 post op, -1.00+2.00x130 20/25, lens at 91 degrees.Day #8 post op, -2.00+4.25x110 20/25 lens at 53 degrees.Then lens rotated from 53 degrees to 95 degrees.It was noted that at day # 1 post op lens rotation -.50+1.00x74 20/20 lens at 95 degrees.Then at day # 8 post op rotation of lens -100+2.00x115 20/20 lens at 68 degrees.There was second lens rotation and repositioned on 12/10/2024 lens rotated from 68 degrees to 95 degrees, post op tomorrow to check on stability.Iol remains implanted.No other information was provided.This report is for the replacement intraocular lens that was repositioned rotationally.A separate report is being submitted for the initial iol that also rotated then explanted.

• 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: 20926067
• Report Number: 3012236936-2024-000334
• Device Sequence Number: 5043175
• Product Code: MFK
• UDI-Device Identifier: 05050474690912
• UDI-Public: (01)05050474690912(17)251126
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

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: 11/26/2025
• Device Model Number: ZLU375
• Device Catalogue Number: ZLU375U090
• 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: 11/18/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2020
• 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 Age: 39 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White