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

Model Number	ZCT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ethnicity: unknown, information not provided.If implanted, give date: not applicable, as lens was removed in the initial surgery.If explanted, give date: not applicable, as lens was removed in the initial surgery.Manufacturer telephone number: (b)(4).The device was not returned for analysis as the lens was discarded.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.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the surgeon had placed intraocular lens (iol) into patient's left eye, however, the lens was cut out during the same procedure due to anatomy issue that the bag failed and there was no support.Surgeon believes that even though the patient posed no apparent pre-existing condition before surgery, patient anatomy and/or pre-existing condition may have both played a role in the patient's bag failure.In addition, surgeon also believes that the "sticky nature" of the lens may have also contributed to the popped capsule.So it was also possible that the placement of the lens contributed as well.There was no other injury to the patient.Vitrectomy was performed and the patient was left aphakic.The patient was disappointed but well post-operation.No further information was available.
Additional Manufacturer Narrative
Corrected data: section h6: health effect - impact code: as part of an internal review of our mdrs it was identified that the code 4631 - removal and replacement provided on the initial report needs to be corrected.Code 4631 is no longer applicable.The correct impact code is 4627 - removal.Health effect - clinical code 4581 was inadvertently not addressed in section h10 for incomplete treatment.Therefore, it is captured in this supplemental filing.The following section has been updated accordingly: section h6: health effect - impact code: 4627 removal.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.Note: acknowledgement 2 for this report was received on 9/22/2022.There was a delay in receiving acknowledgement 3 due to a cdrh system issue.Multiple follow-ups were conducted with the esg help desk.On 10/18/2022 esg responded requesting to resubmit the mdr.Therefore, this report is being resubmitted on 10/19/2022.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; van swietenlaan 5; groningen, groningen 9728 -NX ; NL 9728 NX
• MDR Report Key: 12082205
• Report Number: 9614546-2021-07250
• Device Sequence Number: 3870661
• Product Code: MJP
• UDI-Device Identifier: 05050474552678
• UDI-Public: (01)05050474552678(17)220926
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

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: 09/26/2022
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U170
• Was Device Available for Evaluation?: No
• 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: 06/01/2021
• Supplement Date Received by Manufacturer: 08/28/2022
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC30 CARTRIDGE, LOT # CJ14389
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White