MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	ZXT375
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Discomfort (2330)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted from patient's left eye for an unspecified reason and another johnson & johnson zcu lens of different model and 5.25 diopter was used as the replacement.There was no patient injury nor any medical or surgical interventions required.There was no adverse effects or complaints post-operation.No other information was provided.
Additional Manufacturer Narrative
Patient weight: unknown/ asked but not available.Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2022.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: new information received from the facility revealed that there was no product issue with the explanted lens.But that the reason for explant was patient being unhappy with the lens.Field below updated.Section h6: health effect - clinical code: 2330 - discomfort.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional info: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: jul 22, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The complaint lens was received inside of a specimen cup.Visual inspection under magnification revealed that the complaint lens was received cut in half.The lens was cleaned and, an edge chip was observed, which is consistent with a lens that was removed.No issues that could contribute to or cause visual disturbances were identified.Conclusion: the reported 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.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• 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: 14758060
• Report Number: 3012236936-2022-01632
• Device Sequence Number: 6128234
• Product Code: POE
• UDI-Device Identifier: 05050474606944
• UDI-Public: (01)05050474606944(17)220809
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 10/11/2022

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: 08/09/2022
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U185
• 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: 05/26/2022
• Supplement Date Received by Manufacturer: 07/11/2022; 09/29/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 08/02/2022; 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2017
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian