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

Model Number	DFW150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the doctor observed a defect on an intraocular lens (iol).Looking through the slit lamp it appeared that the center ring was smeared on the lens.The lens remains implanted in the patient¿s left eye, and the doctor is not explanting the lens at this time.Additional information indicated confirmed that the lens remains implanted.That there have been no interventions and no injury reported.The patient has no complaints or issues.No further information was provided.The patient had bilateral lens implantation.This report is for patient¿s left eye.A separate report will be submitted for the right eye of the patient.
Additional Manufacturer Narrative
Section a4 & a5: unknown/ asked but not available.Section b3: date of event: exact date is unknown/not provided.Best estimate date is on or after (b)(6) 2022 (date that the lens implanted).Section d6b: if explanted, give date: not applicable as the device remains implanted.Section h3-other (81): the device was not returned for evaluation as the 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.Attempts have been made to obtain missing information; however, the information was not available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in review, it was noticed that the date ((b)(6) 2022) was inadvertently entered in the section h10 narrative of the initial mdr report in the following sentence "section b3: date of event: exact date is unknown/not provided.Best estimate date is on or after (b)(6) 2022 (date that the lens implanted)." which is incorrect.The correct date that should have been entered is (b)(6) 2022.In review, it was also noted that an incorrect date ((b)(6) 2023) was inadvertently entered in the section g3 of the initial mdr report instead of "(b)(6) 2023"; therefore, the information has been corrected in this supplemental mdr report and the following fields were updated accordingly: section b3: date of event: exact date is unknown/not provided.Best estimate date is on or after (b)(6) 2022 (date that the lens implanted).Section g3: date received by manufacturer: may 23, 2023.All pertinent information available to johnson and 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: 17159616
• Report Number: 3012236936-2023-01541
• Device Sequence Number: 12109143
• Product Code: MFK
• UDI-Device Identifier: 05050474751316
• UDI-Public: (01)05050474751316(17)240224
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: 02/24/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U225
• 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: 05/24/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• 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: 79 YR
• Patient Sex: Female