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

Model Number	DFW225
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the preloaded dfw225 intraocular lens (iol) had a manufacturing defect and the lens cut and removed from patient's right eye; there was patient contact.Through follow-up, additional information was received clarifying reported manufacturing defect as optic surface was defective.The dfw225 iol was fully inserted and cut out.There was no extra measures, no injuries, no sutures, and no vitrectomy required.The same procedure was completed using back-up lens with the same diopter size.No further information is available.
Additional Manufacturer Narrative
Additional information: device evaluated by mfr: 81: 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, 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.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 14-feb-2023.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the suspect lens complaint simplicity was received inside the original folding carton along with the suspect lens wrapped in medical gauze.Visual inspection under magnification revealed that the suspect lens was coated in viscoelastic residue.The lens was cleaned and further inspected under magnification, and the lens damage on the optic of the lens was observed.The complaint simplicity was inspected under magnification and traces of viscoelastic residue as observed.The cartridge was observed to have a stress mark, and cartridge tip was slightly deformed.The plunger rod tip was also observed to be bent.The complaint simplicity was disassembled and inspected, and no assembly issues were observed.Complaint issue "lens damaged" was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: the event date that was reported in the initial mdr: 3012236936-2022-02436 was aug 10, 2022.At a later date an additional event date of nov 08, 2022 was provided with the same reported serial number.Since the event dates were not confirmed, the event date is being reported as unknown.Section g4 combination product was inadvertently not completed in the initial mdr.Therefore, the field has completed in this supplemental report indicating 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: 15549016
• Report Number: 3012236936-2022-02436
• Device Sequence Number: 13917388
• Product Code: MFK
• UDI-Device Identifier: 05050474751699
• UDI-Public: (01)05050474751699(17)240413
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 03/06/2023

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: 04/13/2024
• Device Model Number: DFW225
• Device Catalogue Number: DFW225U120
• 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: 09/19/2022
• Supplement Date Received by Manufacturer: 02/07/2023; 02/28/2023
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 02/23/2023; 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• 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 Sex: Female