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

Model Number	ZCT600
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a toric intraocular lens (iol) was implanted on (b)(6) 2018 and rotated from 110 to 150 degrees after surgery.The prescription did not come out as calculated.The iol was explanted on (b)(6) 2018.The patient outcome was reported as very good.There was no additional invention required.Additional information received revealed the iol was a zct600 and was replace with another zct600 of a different diopter.The reported issue was first identified on (b)(6) 2018.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 01/14/2019.Device returned to manufacturer: yes.Device evaluation: the returned sample was received on 01/14/2019 at jjsv santa ana.The product was forwarded to jjsv puerto rico on 01/14/2019 for lens measurement.The returned lens was measured on 04-feb-19 with all results within specification.The complaint event could not be confirmed.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 other 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.
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 nr-0148919 and capa-010215.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 8254825
• Report Number: 3011852734-2019-00017
• Device Sequence Number: 14023369
• Product Code: HQL
• UDI-Device Identifier: 05050474604070
• UDI-Public: (01)05050474604070(17)230813
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2020
• 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: 08/13/2023
• Device Model Number: ZCT600
• Device Catalogue Number: ZCT600U155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 02/20/2019; 10/25/2020
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 03/16/2019; 11/06/2020
• 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