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

Model Number	ZCT400
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: n/a lens remains implanted.(b)(4).Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the 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.
Event or Problem Description
It was reported that at the 1-day post-op visit, the intraocular lens (iol) implanted in the patient's right eye, was observed to have rotated 24 degrees from the initial placement of 121 degrees to 145 degrees.At the time of the post-op visit, the patient reported blurry vision and felt unbalanced.The lens was rotated, and the patient reported his vision as being good.There were no patient injuries and the iol remained implanted.Additional information received revealed that the iol had rotated again.The iol was repositioned rotationally a second time.Requests were made for specific details on the second rotation, but no details have been provided.No additional information received.This report captures the event for the initial rotation.The second rotation is being reported in a separate mdr.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa-010215.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8621782
• Report Number: 9614546-2019-00471
• Device Sequence Number: 2130389
• Product Code: HQL
• UDI-Device Identifier: 05050474553873
• UDI-Public: (01)05050474553873(17)200310
• Combination Product (Y/N): Y
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2020
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 11/12/2020
• 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: 70 YR
• Date Report Sent to FDA: 01/01/2005