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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Visual Impairment (2138)
Date of Event	06/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by customer that tecnis synergy simplicity intraocular lens (dfr00v) of 22 diopter was explanted from patient's right eye and replaced with tecnis simplicity symfony lens (dxr00v), 21 diopter in a secondary surgical procedure.Additional information received stated that the reason for explant was power miss.Patient had dry eye.There was no injury.However sutures were reported.Patient is improving.The lens was scrapped and will not be returned.No further information is available.
Additional Manufacturer Narrative
Section h3: other 81: the device was not returned for evaluation as the lens 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information received on 9/8/2023 stated that the patients pre op uncorrected was 20/80 with +1.50-0.75x135 correction 20/60 on (b)(6) 2023 surgery.On (b)(6) 2023, it was -0.25-0.50 x135 20/50, on (b)(6) 2023, it was -0.75-0.50 x150 20/40, and on (b)(6) 2023, it was -0.75-0.50 x150 20/30.It was stated that it was uncertain why doctor put a suture in.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: 17715930
• Report Number: 3012236936-2023-02318
• Device Sequence Number: 2226404
• Product Code: MFK
• UDI-Device Identifier: 05050474750715
• UDI-Public: (01)05050474750715(17)240929
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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: 09/29/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU220
• 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: 08/14/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White