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

Model Number	ZXT225
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	10/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, but the best estimate is between (b)(6) 2018 and (b)(6) 2018.If explanted, give date: to date the lens remains implanted but it was planned to be explanted (date unknown).(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that there was a refractive miss after the implantation of the symfony toric intraocular lens (iol) in the patient's left eye.Reportedly, the lens had rotated post-op and it was 20 degrees off axis from the intended orientation.The patient complained of blurry vision ou (both eyes).The lens is planned to be exchanged.No further information was provided.
Additional Manufacturer Narrative
Additional information received revealed the 20 degree rotation was noted on (b)(6) 2018.The explant was performed on (b)(6) 2018.The patient was doing fine post-op.No additional surgical intervention was required.The explanted iol was discarded.The patients date of birth was provided as (b)(6) 1945.As a result the following fields have been updated.Date of birth: (b)(6) 1945.Date of event: (b)(6) 2018.Date of explant: (b)(6) 2018.Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed that no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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, INC.; santa ana CA 92705
• MDR Report Key: 8109844
• Report Number: 9614546-2018-01119
• Device Sequence Number: 11192984
• Product Code: POE
• UDI-Device Identifier: 05050474605848
• UDI-Public: (01)05050474605848(17)221222
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• 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: company representative,health
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/22/2022
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U225
• 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: 11/02/2018
• Supplement Date Received by Manufacturer: 11/28/2018; 10/25/2020
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 12/28/2018; 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005