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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2018 and (b)(6) 2018.The lens remains implanted.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zct400 9.0 diopter lens was implanted in the patient's left eye (os) on (b)(6) 2018 at an axis of 170 degrees.Post-operatively, the lens rotated, and therefore, the patient underwent a lens repositioning procedure on (b)(6) 2018.Not additional information was provided.
Additional Manufacturer Narrative
Additional information: additional information received clarified that the 18 degree difference was obtained as the counting is done to 180 degrees, not 360.The iol was placed at 170 degrees at surgery.At the postop visit, it was measured at 8 degrees and this means that the iol rotated from its original placement.So, it was counted from the starting point of 170 degrees towards 180 degrees (10 degrees) and then 8 more degrees to the 1-day visit location of 8 degrees, which that is a total of 18 degrees rotation.It was also indicated that there was only one rotation and the iol repositioning was successful.It was reported that lens remains implanted and that the patient recovered.The following fields were updated based on the new received information: age at time of event: (b)(6) yrs.Sex/ gender: female.Device evaluation: a product evaluation/ investigation was not performed as no product was returned (the lens remains implanted).The complaint cannot be confirmed.Manufacturing record review: manufacturing records were reviewed and the device was manufactured according to specifications.A complaint history search revealed no similar complaints were received for this production order number to date.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.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
• MDR Report Key: 7380514
• Report Number: 9614546-2018-00300
• Device Sequence Number: 1160337
• Product Code: HQL
• UDI-Device Identifier: 05050474553699
• UDI-Public: (01)05050474553699(17)180828
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 08/28/2018
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U090
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 06/14/2018
• 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: 65 YR