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

Model Number	ZXR00
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 2 events are as follows: cosmetic issues - 1, haptic damaged - 1.Serial numbers of suspect products: (b)(4).Site address: for the sn starting with (b)(4) the manufacturing site address is as follows: (b)(4).1 investigation was completed and 1 investigation is pending from this period.From the 1 investigation completed the product was not returned back.In the investigations it was concluded that products met manufacturing release criteria and no product deficiency was identified.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 2 malfunction events.The events were 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 (b)(4) and capa (b)(4).
Additional Manufacturer Narrative
Section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: 03/31/2020.Section h3: device returned to manufacturer: yes.There are 1 investigations completed during this period.The breakdown of 1 investigation is serial numbers (b)(6), no issues were identified.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
• 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: 9998907
• Report Number: 2648035-2020-00388
• Device Sequence Number: 3896178
• Product Code: POE
• UDI-Device Identifier: 05050474591691
• UDI-Public: (01)05050474591691
• Combination Product (Y/N): Y
• PMA/510(K) Number: P980040
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: ZXR00
• Device Catalogue Number: ZXR00U0125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• 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: 04/10/2020; 10/25/2020
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 07/22/2020; 10/28/2020
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005