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	12/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight, ethnicity and race: unknown.Date implanted: not applicable, as the iol was removed and replaced during the same procedure.Date explanted: not applicable, as the iol was removed and replaced during the same procedure, thus not explanted.The device was not returned for analysis.Therefore, a visual analysis of the complaint device cannot be completed.A review of the device history record and historical data analysis 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.Health effect - impact code: 4631 iol removal and replacement.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
After the dfr00v intraocular lens (iol) was fully inserted into the patient's ocular dexter (right eye) it was reported the lens was scratched.The iol was removed and the same procedure was completed using another iol with the same model and a different diopter size, dfr00v 21.5 diopter.Outcome does not significantly interfere with activities of daily life and it was reported the patient has recovered.
Additional Manufacturer Narrative
Corrected data: in review, it was noticed that the updated verbiage for the field "h3-other (81)" was inadvertently not used in the section "h10" of the initial mdr report; therefor, the information has been corrected in this supplemental mdr report and the following field was updated accordingly: h10: section h3-other (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 will be filed.Additional information: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 27-feb-2023.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received wrapped in gauze.The complaint handpiece, folding carton, patient identification (id) card, implant notification card, patient stickers, and direction for use (dfu) were received as well.Visual inspection under magnification after lens cleaning revealed that the lens was received with a cut, edge chip, and edge tear.Plunger rod damage (bent) was observed consistent with excessive force during delivery.No additional defects or assembly issues were observed before and after disassembling the handpiece for evaluation.The complaint issue of ¿cosmetic issues¿ was not confirmed.The other observed issues found during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.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: 16415121
• Report Number: 3012236936-2023-00338
• Device Sequence Number: 14328792
• Product Code: MFK
• UDI-Device Identifier: 05050474750692
• UDI-Public: (01)05050474750692(17)250506
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2023

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: 05/06/2025
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU210
• 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: 01/26/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2022
• 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
• Patient Sex: Female