MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. 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 Code	Visual Impairment (2138)
Date of Event	07/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's left eye.It was replaced with a non johnson and johnson iol.The suspect iol pieces were discarded.No further information provided.
Additional Manufacturer Narrative
Weight, ethnicity unknown/ not provided.Date of event: unknown, not provided.Best estimate date of event is between may 29, 2018 and jan 4, 2022.Manufacturer: device was manufactured at the (b)(4); however, this site has been closed.If explanted, give date: unknown/not provided.The device was not received 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 have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information and corrected data: upon further review, it was identified that event date was (b)(6) 2018 and that it was inadvertently missed to indicate in h0 in the initial report submitted that "section d3: manufacturer: device was manufactured at the kulim site in malaysia; however, this site has been closed".These fields are being updated and this report submitted as correction.Section b3: date of event: (b)(6) 2018.Section d3: manufacturer: device was manufactured at the kulim site in malaysia; however, this site has been closed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13261841
• Report Number: 3012236936-2022-00134
• Device Sequence Number: 14634487
• Product Code: MJP
• UDI-Device Identifier: 05050474552814
• UDI-Public: (01)05050474552814(17)210606
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 03/11/2022

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: 06/06/2021
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U240
• 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: 01/04/2022
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2017
• 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: Female