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

Model Number	ZXT225
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: not applicable as the iol was not implanted.If explanted; give date: not applicable as the iol was not implanted.Attempts were made to obtain missing information; however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported when removing zxt225 18.0 diopter intraocular lens (iol) from packaging the haptic was distorted.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Product testing could not be performed because the product was not returned.A product quality deficiency could not be confirmed.During the manufacturing record review of the production order for this serial number, no product deficiency was identified.The documentation shows that the production order was manufactured according to specifications.A search of complaints revealed no other complaints have been received for this production order number.The labeling review was completed and revealed that the directions for use (dfu) provide the customer with proper usage instructions and guidelines.No labeling changes are required.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.
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 SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 8113368
• Report Number: 9614546-2018-01121
• Device Sequence Number: 2165835
• Product Code: POE
• UDI-Device Identifier: 05050474605756
• UDI-Public: (01)05050474605756(17)211108
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 11/08/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U180
• 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: 10/31/2018
• Supplement Date Received by Manufacturer: 11/29/2018; 10/25/2020
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 12/14/2018; 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