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

Model Number	ZCT225
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: the reported event of lens damage was related to a cosmetic issue.The product was returned.The investigation for the event was completed and a operational problem was found.Based on the investigation there is no indication of a product malfunction or product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.That was received during the time period that covers this voluntary malfunction summary report has been submitted.
Event or Problem Description
This report summarizes 1 malfunction events.The event was related to lens damage.There was no patient injury reported associated to the event.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f and g.4 date 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.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8563565
• Report Number: 9614546-2019-00381
• Device Sequence Number: 11317840
• Product Code: HQL
• UDI-Device Identifier: 05050474552456
• UDI-Public: (01)05050474552456(17)220114
• Combination Product (Y/N): Y
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020
• 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: No Information
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U060
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/14/2005
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 10/28/2020
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005