MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; TORIC IOLS

Model Number	ZCT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.(b)(4).An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zct150 11.5 diopter lens was implanted in the patient's operative eye on (b)(6) 2017.It was later explanted on (b)(6) 2017 and replaced with a zct300 11.5 diopter lens.No additional information was provided.
Additional Manufacturer Narrative
Through follow up the following additional information was provided; the lens was explanted due to an unexpected post-op refraction.There was no visual acuity issue and the contact could not confirm if the patient had any contributing medical histories.There were no patient injury, no vitrectomy, and no incision enlargement.The patient was reported to be doing fine post-op.In addition the following information was also provided therefore, the following fields have been updated accordingly: age: 85.Gender: male.(b)(6).Health professional: yes.Occupation: physician.Additional patient code - 3191 unexpected post-op refraction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 04/26/2018.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection showed that the product was cut in pieces, most probably to make the explant possible.Considering the condition of the lens additional analysis was not possible.The customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7446486
• Report Number: 9614546-2018-00360
• Device Sequence Number: 2053637
• Product Code: HQL
• UDI-Device Identifier: 05050474551978
• UDI-Public: (01)05050474551978(17)190618
• Combination Product (Y/N): Y
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2018
• Report Date (Section F): 01/01/2005

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: Physician
• Device Expiration Date: 06/18/2019
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 04/23/2018; 06/25/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 05/21/2018; 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Date Report Sent to FDA: 01/01/2005