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

Model Number	ZCT300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	04/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, as 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 zct300 26.0 diopter lens was implanted in the patient's left eye (os) on (b)(6) 2018 at an axis of 002 degrees.Post-operatively on (b)(6) 2018, at the patient's follow up visit, the patient had blurred vision secondary to a shift in the cornea which created a shift in the axis of cylinder causing the lens axis to change to 010 degrees.Therefore, a lens repositioning procedure was performed on (b)(6) 2018.Reportedly, there was no patient complications and/or related injury.Outcomes did not significantly interfere with activities of daily life.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site as to date it remains implanted; 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 intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional 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.
Additional Manufacturer Narrative
Additional information was received which reported the subject came in for a 6-month study visit on (b)(6) 2018 and the intraocular lens (iol) axis was measured as follows: os: 165 degrees (9 degrees from iol repositioned location of 156 degrees).Iol reposition occurred on (b)(6) 2018.Currently there is no planned intervention for the new rotation.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7594300
• Report Number: 3011852734-2018-00100
• Device Sequence Number: 217663
• Product Code: HQL
• UDI-Device Identifier: 05050474553446
• UDI-Public: (01)05050474553446(17)210806
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2019
• 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: Physician
• Device Expiration Date: 08/06/2021
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 06/27/2018; 02/12/2019
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 07/10/2018; 03/06/2019
• 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: 80 YR
• Date Report Sent to FDA: 01/01/2005