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	Blurred Vision (2137); Discomfort (2330)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the dfr00v model intraocular lens (iol) was implanted into the patient¿s operative eye.Due to complaints of dissatisfaction, the iol was explanted in a secondary surgical procedure and replaced with a dib00 iol.No further information is available.
Additional Manufacturer Narrative
Additional information: sections a-2 patient age/date of birth, a-4 patient weight, and a-5 patient ethnicity and race: unknown/asked information unavailable.Section b-3: date of event: unknown/asked information unavailable.Section d-6a date implanted: unknown/asked information unavailable.Section h3-81: the device was not returned for evaluation.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 report will be filed.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Through follow-up, additional information was received stating patient ocular dexter (right eye) visual issues were blurry vision-distorted.There was no incision enlargement, no serious patient injury, no suture(s), and no vitrectomy during the lens exchange procedure.The suspect iol is not available for return as it was discarded.Patient demographics information was also provided as well as dates regarding iol implant and visual symptoms first observed.No further information is available.The following fields were updated based on the information received through follow-up: section a-2 patient date of birth: (b)(6) 1981.Section a-3 patient gender: female - previously reported: no information is no longer applicable.Section a-4 patient weight in pounds: 134.Section a-5 patient ethnicity: not hispanic or latino.Section a-5 patient race: white.Section b-3 date of event: 10-oct-2023.Section d-6a date implanted: (b)(6) 2023.Section h-6 health effect - clinical code: 2137-bluured vision - previously reported health effect - clinical code: 2330 is no longer applicable.Section h-6 type of investigation: 4115 - device discarded - previously reported code: 4114 is no longer applicable.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: 18891998
• Report Number: 3012236936-2024-00668
• Device Sequence Number: 6189153
• Product Code: MFK
• UDI-Device Identifier: 05050474750418
• UDI-Public: (01)05050474750418(17)250303
• 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: 2023
• Device Explanted Year: 2024
• 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): 04/10/2024

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: 03/03/2025
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU070
• 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: 02/22/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• 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 Age: 42 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White