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	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age, weight, ethnicity: unknown; requested but not provided.If implanted; give date: the intraocular lens was inserted and removed during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.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.Attempts were made to obtain the missing information; however, 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 preloaded intraocular lens (iol) had a defect noted upon insertion.The lens was cut out and removed.It is unknown if another lens was implanted.No further information was provided.
Additional Manufacturer Narrative
Additional information: account provided that the intraocular lens (iol) was fully inserted and the lens defect was noted upon insertion.The affected eye was the left eye.There was no tech loading error.Another johnson and johnson iol was used as replacement (same model and diopter).The patient is female.Patient's date of birth is (b)(6) 1951.Surgeon (initial reporter) name is (b)(6).The following sections have been updated accordingly: section a2: date of birth: (b)(6) 1951.Section a3: gender: female.Section b5: describe event or problem: the intraocular lens (iol) was fully inserted and the lens defect was noted upon insertion.The affected eye was the left eye.There was no technician loading error.The replacement lens was another johnson and johnson iol of the same model and diopter.Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: mar 10, 2023.Section e1: reporter name and address: contact: title: dr.Section e1: reporter name and address: contact: first/given name: (b)(6).Section e1: reporter name and address: contact: last name: (b)(6).Section e3: occupation: physician.Section h3: evaluated by manufacturer: yes.Section h6: health effect - impact code: code: 4631 - more complex surgery, to capture removal and replacement.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed that the complaint lens was received cut in half.The lens was cleaned and, damage on the side of the spare tire could be observed on one half.Based on the return condition of the lens, no further product evaluation could be performed.Visual inspection under magnification revealed that the complaint handpiece was received with the plunger rod fully advanced.The handpiece was disassembled, and the assembly was inspected, no issues that could contribute to or cause the observed issues could be identified.The complaint issue lens damage 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.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.Correction: with the additional information received, section h6: health effect - impact code was changed from code 4627 - device explantation (which originally captured the report of iol removal) to code 4631 - more complex surgery, to capture the iol removal and replacement.The surgeon's name (initial reporter) was also provided as additional information, which was originally reported as "debbie kent".Therefore this information has been captured in this supplemental report.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: 16519386
• Report Number: 3012236936-2023-00623
• Device Sequence Number: 20461826
• Product Code: MFK
• UDI-Device Identifier: 05050474751927
• UDI-Public: (01)05050474751927(17)240315
• 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
• Report Date (Section B): 04/06/2023

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: 03/15/2024
• Device Model Number: DFW225
• Device Catalogue Number: DFW225U235
• 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: 02/14/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/06/2023
• 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 Sex: Female