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

Model Number	ZXT225
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Scratched Material (3020)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.Best estimate of date of event is between (b)(6) 2018.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zxt225, 20.0 diopter intraocular lens (iol) was explanted from the patient¿s left eye (os) due to lens dislocation and possible scratch.Reportedly, lens removal was because at the post-op visit under slit lamp, there appeared to be a smudge on lens, not apparent at the time of insertion.The patient was very distressed as the objects were distorted and the patient could not tolerate the distortion.It was indicated that the patient has excellent distance vision and near acuity on half.The doctor made a new incision (not an enlarged incision) and the lens was removed and was replaced with another manufacturer's iol (19.5 diopter), no sutures required.The patient is reported to be doing fine.No other information was provided.
Additional Manufacturer Narrative
Additional information: device available for return? yes.Returned to manufacturer on: 11/5/2018.Device returned to manufacturer? yes.Device evaluation: visual inspection with the unaided eye shows that the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specifications.Historical data analysis: a search of complaints related to production order number was performed.The search revealed that no similar complaints were received for this production order.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 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 AND JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7993333
• Report Number: 9614546-2018-00992
• Device Sequence Number: 19182200
• Product Code: POE
• UDI-Device Identifier: 05050474605794
• UDI-Public: (01)05050474605794(17)210804
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/04/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 11/08/2018; 10/25/2020
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 12/06/2018; 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005