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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens was explanted from a patient¿s left eye as the patient complained of double vision side to side and a glow.A non-johnson and johnson lens was used as the replacement.There were no surgical and/or medical interventions required and no patient injury reported.The patient is doing well post-op.No further information is available.
Additional Manufacturer Narrative
The intraocular lens (iol) 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: dec 9, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received in a bag.No additional materials were received.Visual inspection under magnification revealed that the complaint lens was received cut in half.The lens was cleaned and, no issues that could contribute to or cause the complaint issues were observed.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issues were not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information received from customer indicated that they filled out the wrong information when they did the return process for the left (os) eye of the patient.As a result, the incorrect sn (2335192132) which pertained to the patient's right (od) eye was inadvertently entered in the initial mdr report.The correct sn for the patient's left eye which should have been entered in the initial mdr report is 8029872108.In review, it was also noted that the "g4 -combination product" field was inadvertently not populated in the initial mdr report; therefore, the information has been corrected in this supplemental mdr report and the following fields were updated accordingly: section d3: manufacturer/establishment name: amo manufacturing netherlands section d3: manufacturer country: netherlands section d3: manufacturer address - line 1: (b)(6) section d3: manufacturer city: (b)(6) section d3: manufacturer state, province or territory: (b)(6) section d3: manufacturer postal office or zip code: (b)(6) section d4: catalog #: dfr00vu185 section d4: serial #: (b)(6) section d4: expiration date: feb 23, 2024 section d4: udi #: (b)(4) section g4: combination product: no section h4: device manufacture date: feb 23, 2021 all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in review, it was noticed that the product investigation that was submitted in the supplemental mdr report #1 did not pertain to the suspect lens, sn (b)(6) involved in this case.That per the investigation results, no product was received for serial number (b)(6); therefore, no visual evaluation was able to be performed.Therefore, the information has been corrected in this supplemental mdr report and the following field was updated accordingly: device evaluation: the product testing could not be performed as the product was not returned for evaluation.The reported complaint cannot be confirmed.All pertinent information available to johnson and 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 PR 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15883157
• Report Number: 3012236936-2022-02962
• Device Sequence Number: 5016388
• Product Code: MFK
• UDI-Device Identifier: 05050474750647
• UDI-Public: (01)05050474750647(17)240223
• 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
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU185
• 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: 11/03/2022
• Supplement Date Received by Manufacturer: 12/19/2022; 10/02/2023; 12/13/2023
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 01/11/2023; 10/26/2023; 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White