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

Model Number	ZCT225
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown, not provided.Best estimate of date of event is (b)(6) 2018.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.The search in the complaint history revealed that no similar has been received for this production order number.Labeling review: the labeling review was completed and revealed that the directions for use (dfu) provide the customer with proper usage instructions and guidelines.Conclusion: 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 a zct225, 21.0 diopter intraocular lens (iol) was implanted in the eye of a female patient on (b)(6) 2018.Reportedly, the lens rotated from the original placement and it was repositioned one week after the initial surgery.The surgeon placed a ctr (capsular tension ring) and sutured the wound but the lens rotated again; so it was explanted and replaced with a non-johnson & johnson lens.It was learnt that the iol rotated 50 degrees.There was unexpected post-op refraction.There was no incision enlargement, no vitrectomy was performed and no patient post-op injury occurred.The explanted lens was discarded by the account.No other information was provided.
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 AND JOHNSON SURGICAL VISION, INC.; 1700 east st. andrew place; santa ana CA 92705
• MDR Report Key: 8247449
• Report Number: 9614546-2019-00045
• Device Sequence Number: 16714191
• Product Code: HQL
• UDI-Device Identifier: 05050474552753
• UDI-Public: (01)05050474552753(17)220327
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• 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: 03/27/2022
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U210
• 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: 12/18/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 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
• Date Report Sent to FDA: 01/01/2005