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

Model Number	ZCT450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	03/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant and explant dates: if implanted or explanted, give date: not applicable, as the lens was inserted and removed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient's capsular bag tore after a zct450 5.0 diopter lens was implanted in the patient's left eye (os).The lens was then cut, removed from the operative eye, and replaced with another manufacturers lens.There was no incision enlargement, no vitrectomy, and no sutures used.Reportedly, there was no patient injury and the patient is doing fine post-operatively.There was no medical intervention outside of the routine post-operative management.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The 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 & 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 92705
• MDR Report Key: 7404284
• Report Number: 9614546-2018-00328
• Device Sequence Number: 13649615
• Product Code: HQL
• UDI-Device Identifier: 05050474602687
• UDI-Public: (01)05050474602687(17)220327
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2018

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: 03/27/2022
• Device Model Number: ZCT450
• Device Catalogue Number: ZCT450U050
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 05/02/2018
• 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: Other