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

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b-3: date of event: unknown/asked information unavailable.The best estimation date is between (b)(6) 2024 (iol implant and explant dates).Section h3-81: 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 report will be filed.Attempts were made to contact the customer account requesting additional information regarding complaint 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 the model zlb00 intraocular lens (iol) was implanted into the patient¿s ocular sinister (left eye).In a secondary surgical procedure, the iol was explanted due to unknown reasons and replaced with a zlb00 23.5 diopter iol.Patient prognosis post lens exchange is unknown.No further information is available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: device date returned to manufacturer: 15-apr-2024.Section h3: device evaluated by manufacturer: yes.Device evaluation: the lens was received in a specimen cup.The device was inspected under magnification.The complaint lens was received cut in half, covered in viscoelastic, and with the haptics cut off/missing.The lens was cleaned and presented with no issues that would have caused or contributed to the complaint event.Complaint issue "hm-unspecified injury" and "pt-explant" were not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the complaint investigation results, the product was released within specifications and the reported complaint issues could not be confirmed.No product deficiency or product malfunction was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Further information was provided and reported the replacement (b)(6) iol implant date was (b)(6) 2024.Therefore, it can be inferred the suspect (b)(6) iol has an explant date of (b)(6) 2024 and not (b)(6) 2024 as originally reported.The corrected information is captured in this supplemental report.No other information was provided.The following fields were updated accordingly: section d-6b date explanted: (b)(6) 2024.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: 19102367
• Report Number: 3012236936-2024-01117
• Device Sequence Number: 7428016
• Product Code: MFK
• UDI-Device Identifier: 05050474560697
• UDI-Public: (01)05050474560697(17)270125
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 08/29/2024

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 Model Number: ZLB00
• Device Catalogue Number: ZLB00U0210
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 05/15/2024; 08/08/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 05/15/2024; 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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 Sex: Male