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

Model Number	DFR00V
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight: unknown/asked, but unavailable.If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.The device was not returned for analysis.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.An attempt was made to obtain missing information; however, the information was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that upon injection of the intraocular lens (iol) there was a scratch that was made by the injector as it was pushing the lens into the patients left eye.It was confirmed that the lens was fully inserted into the patients eye when the scratch was noticed and that the tip of the cartridge was not damaged/broken.The lens was cut out and removed from the eye.A backup lens of the same model and diopter was used as replacement during the same procedure.It was indicated that balanced salt solution (bss) was used.The lens was continually lubricated until it was handed to the surgeon.There were no surgical interventions required and no patient injury reported.The patient outcome is unknown due to having post-operative appointments with another doctor and the account has not received post-operative notes on the patient.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: nov 7, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received inside a glass vial.No additional materials were received.Visual inspection under magnification was performed and the lens was observed to be cut into 5 pieces with a detached haptic, which is consistent with a lens that was explanted.One piece of the lens and the detached haptic were not returned.The lens was cleaned and, no further issues could be identified.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue cosmetic issues was not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Corrected data: in review, it was noted that "g4 -combination product" field inadvertently was left blank and not populated in the initial mdr report.The information has been captured in this supplemental mdr report and the following field was updated accordingly: section g4: combination product: no.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: 15713103
• Report Number: 3012236936-2022-02739
• Device Sequence Number: 6675563
• Product Code: MFK
• UDI-Device Identifier: 05050474750494
• UDI-Public: (01)05050474750494(17)240315
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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: 03/15/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/06/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2021
• 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: 46 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White