MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS SIMPLICITY; INTRAOCULAR LENS

Model Number	DEN00V
Medical Device Problem Codes	Operating System Becomes Nonfunctional (2996); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: sections a-2 patient age and date of birth and a-4 patient weight: unknown/asked information unavailable.Section d-4 catalog number: a complete catalog number is unknown, as device serial number was not provided.Section d-4 device serial number: unknown as information was not provided.Section d-4 device expiration date: unknown as device serial number was not provided.Section d-4 udi number: the unique device identifier (udi) number is unknown as device serial number was not provided.Section d-6a date implanted: not applicable, as the iol was removed and replaced during the same procedure.Section d-6b date explanted: not applicable, as the iol was removed and replaced during the same procedure, therefore not explanted.Section h3-81: device lot/serial number is not available; therefore, no further investigation can be performed.The device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.If there is any further relevant information a supplemental medwatch will be filed.Section h-4 device manufacture date: unknown, as device serial number was not provided.Section h-6 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
It was reported upon implantation of the dcb00 intraocular lens (iol), the optic was scratched.Doctor had difficulty with inserter/plunger and stated scratch on optic was due to the inserter.Iol was removed and a back-up iol was inserted without issue.There was no incision enlargement, no suture(s), and no vitrectomy.There was also no procedural delay, no medical attention, and no medication were required.Patient status post-procedure was reported as fully recovered.Subject vision is 20/25-2.Slit lamp was normal and no subject complaints were reported.Through follow-up additional information was received confirming the iol was fully inserted when scratch on optic was observed.The replacement iol was the same model and diopter size.No further information was provided.
Additional Manufacturer Narrative
Additional information/corrected data: additional information was received for the product, which included the device model and serial number, as the clinical study was unmasked.The initial report was submitted under an unknown dcb00 clinical study device.The clinical study has now been unmasked and upon learning the model of the lens, not dcb00 as initially reported but den00v.It was realized that this report was submitted for an investigational device that is not same or similar to a marketed device in the united states.Therefore, the information in section d-1 and d-2 and section g-4 pma number p980040 that were provided in the initial filing are not applicable and the reported event is now determined not mdr reportable.No further information will be provided for this event under mdr number.The following fields have been updated accordingly: section d-3: establishment name: amo manufacturing netherlands.Section d-3: country: other - netherlands.Section d3: address - line 1: van swietenlaan 5.Section d3: city: groningen.Section d3: state, province or territory: groningen.Section d3: postal office or zip code: (b)(6).Section d-4: model number: den00v.Section d-4: catalog number: den00vu190.Section d-4: serial number: (b)(6).Section d-4: expiration date: jul 20, 2025.Section d-4: unique identifier (udi) number: (b)(4).Section h-4: manufacture date: jul 20, 2022.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen PR 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16687060
• Report Number: 3012236936-2023-00811
• Device Sequence Number: 6080488
• Product Code: HQL
• UDI-Device Identifier: 05050474806436
• UDI-Public: (01)05050474806436(17)250720
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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: 07/20/2025
• Device Model Number: DEN00V
• Device Catalogue Number: DEN00VU190
• 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: 03/15/2023
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White