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

Model Number	ZCT450
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If explanted, give date: not applicable as lens remains implanted.Device evaluation: the product testing could not be performed as the product remains implanted in the patient¿s eye.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 specifications.A search in complaint history was performed which revealed that no similar complaints have 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 malfunction or product quality deficiency and the reported issue could not be verified.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zct450, 16.5 diopter intraocular lens (iol) study lens was placed at os (left eye) 113 degrees at surgery ((b)(6) 2016) and was measured at the 1 month study visit ((b)(6) 2016) at 102 degrees.It was stated that there was no patient injury.The outcome did not effect the patient's daily life activity.There was no lens repositioning done.Additional information was received, and it was learnt that the patient was doing fine as of their final study visit and exit date on (b)(6) 2016.Reportedly at that visit, the iol axis os was recorded as 116 degrees.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: 8092489
• Report Number: 9614546-2018-01099
• Device Sequence Number: 16550803
• Product Code: HQL
• UDI-Device Identifier: 05050474602915
• UDI-Public: (01)05050474602915(17)200616
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2020
• Device Model Number: ZCT450
• Device Catalogue Number: ZCT450U165
• 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: 10/25/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005