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

Model Number	ZXT225
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: breakdown of 3 events: iol torn 2.Haptic damaged 1.Serial numbers of suspect products: (b)(4).Investigations are pending from this period.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.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 3 malfunction events.The event was related to lens damaged.There were no patient injuries reported associated to the events.
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.
Additional Manufacturer Narrative
Additional information was received for serial number (b)(6) that was initially reported in previous quarter.Based on additional information there was indication of incision enlargement.Hence a 30-day serious injury report was reported to fda with mfr report number: 9614546-2020-00053.There were 2 investigations completed during this period.Breakdown of 2 investigations with respective serial numbers are as follows: (b)(6) - lens damaged.(b)(6) - cosmetic issues, iol torn.The investigations concluded that product met manufacturing release criteria and no product deficiency was identified.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.
Additional Manufacturer Narrative
Additional information: there was 1 investigation completed during this period.The breakdown of 1 investigation is serial number (b)(6) the product was not returned.The investigations concluded that product met manufacturing release criteria and no product deficiency was identified.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.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9648597
• Report Number: 9614546-2020-00042
• Device Sequence Number: 19521981
• Product Code: POE
• UDI-Device Identifier: 05050474605657
• UDI-Public: (01)05050474605657
• Combination Product (Y/N): Y
• PMA/510(K) Number: P980040
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,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: ZXT225
• Device Catalogue Number: ZXT225U130
• 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: 01/14/2005; 04/02/2020; 10/25/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 04/27/2020; 07/22/2020; 10/28/2020
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005