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

Model Number	DFR00V
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section a-2 patient age/date of birth: unknown/asked information was not provided.Section a-3b patient gender: female was the answer provided.Section a-4 patient weight: unknown/asked information was not provided.Section a-5 patient ethnicity: unknown/asked information was not provided.Section a-6 patient race: unknown/asked information was not provided.Section d-6b date explanted: not applicable as the iol remains implanted; therefore, not explanted.Section h-3 device evaluated by manufacturer: the device was not returned for evaluation as it 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 report will be filed.Section h-6 health effect - clinical code: 2140 - glare - transient and visual disturbance-dysphotopsia - transient.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The pre-loaded dfr00v model intraocular lens (iol) was implanted in the patient¿s ocular sinister (left eye).Patient reports double vision with glare and halos.Patient is unable to drive and read.An explant is scheduled but has not been confirmed to have taken place.No further information is available.
Additional Manufacturer Narrative
Additional information was received stating the iol was explanted in a secondary surgical procedure and replaced with a non-j&j iol (alcon cc60wf).The patient was dissatisfied with the iol results.Per the doctor, there was no issue with the iol he implanted the wrong lens.Best corrected visual acuity (va) pre-operative was reported as 20/40-2 and post-operative was 20/70-2.There was no procedural delays, incision enlargement, sutures, nor vitrectomy during the lens exchange procedure.No medical attention was required and there was no medication prescribed (outside of standard care).The iol directions for use were followed.The suspect iol is not available for return as it was discarded.Patient demographics information was also provided.No further information is available.The following sections have been updated accordingly: section a2 patient date of birth: (b)(6) 1957.Section a5 patient ethnicity: not latino.Section a6 patient race: white.Section d6b date explanted: (b)(6) 2024.Section h3: device evaluated by manufacturer: yes.Section h6 health effect: impact code: 4629 iol explant.The code provided in the initial report 2199: no health consequences or impact is no longer applicable.Section h6 device code: 1670: use error.Device evaluation: product evaluation was not performed because the product has not been received.If product is received after initial closure, the pi and cp (if necessary) may be re-opened to complete the return investigation.The complaint issue reported could not be confirmed.The manufacturing records for the product were reviewed, the units were released in accordance with specifications.The search revealed that no other complaints were received for this production order (po) number.Conclusion: based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction was identified.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: 20765464
• Report Number: 3012236936-2024-000312
• Device Sequence Number: 15778588
• Product Code: MFK
• UDI-Device Identifier: 05050474750630
• UDI-Public: (01)05050474750630(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: 2024
• 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): 12/27/2024

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: DFR00VU180
• 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: 11/04/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White