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

Model Number	DFR00V
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable as the iol was not implanted.If explanted, give date: not applicable as the iol was not implanted therefore not explanted.The device has not been 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.Attempts have been made to obtain the missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the johnson and johnson (jnj) intraocular lens (iol) had a bent/broken haptic.The issue was noticed during handling of the device and prior to insertion.There was no contact with the product.The procedure was completed using a backup device of the same model and diopter.The outcome of this event did not interfere with the patient¿s daily activities.No further information was provided.
Additional Manufacturer Narrative
Additional information.Customer provided the doctor¿s first name and initials.Section e1 initial reporter, first name: (b)(6).Section e1 initial reporter, middle name: (b)(6).Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: may 19, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: the complaint lens was received.Visual inspection under magnification revealed that the complaint lens was received stuck inside of the original handpiece.The lens could also be observed to be overridden by the plunger rod.The plunger rod could be observed to be damaging the cartridge neck.The handpiece was disassembled, and the assembly was inspected, revealing no assembly issues that could cause or contribute to the complaint or observed issue.The plunger rod could be observed to be bent, in a way consistent with plunger rod that had excessive force applied to it.The lens could not be removed from the cartridge; however, inspection in the cartridge did not reveal damage to either haptic.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.Please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction.It was noted that in the follow-up emdr report submitted, in section h6: type of investigation, investigation findings and investigation conclusions, was left blank.Therefore, it has been corrected in this supplemental report.The following field was updated accordingly.Section h6: type of investigation: 10.Section h6: investigation findings: 114.Section h6: investigation conclusion: 4315.Please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
This is to correct the submission for follow-up #1 section b4 date of this report, was left blank but should have stated june 15, 2023 section b4 date of this report: june 15, 2023 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: 16916675
• Report Number: 3012236936-2023-01132
• Device Sequence Number: 6921432
• Product Code: MFK
• UDI-Device Identifier: 05050474750548
• UDI-Public: (01)05050474750548(17)240328
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup,Followup
• Report Date (Section B): 06/20/2023

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: 03/28/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU135
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 06/15/2023; 06/15/2023; 06/19/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 06/15/2023; 06/15/2023; 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2021
• 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: 71 YR
• Patient Sex: Male