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

Model Number	ZXR00
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As lens was removed/replaced in the initial surgery.(b)(6).Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under 12x microscope magnification was performed by a qualified final inspection manufacturing specialist showed no dirt or particle was found.The lens is considered good and passed cosmetic inspection.The complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints have been 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.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson vision has been submitted.
Event or Problem Description
It was reported that the tecnis symfony multifocal intraocular lens (model zxr00, +24.5 diopter) tore on upon insertion into the eye.The lens was removed and replaced in the same procedure.Reportedly a vitrectomy, incision enlargement and sutures were required.No further information provided.
Additional Manufacturer Narrative
Additional information: it was learnt that there was no patient injury.Patient was doing great without any adverse event.Date of birth: (b)(6) 1967.Gender/sex: female.The physicians involved in the case were also provided.The following has been updated accordingly: dr.(b)(6).Health professional: yes.Occupation: physician.All pertinent information available 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 (b)(4) and capa-010215.

• Brand Name: TECNIS SYMFONY
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7976176
• Report Number: 9614546-2018-00972
• Device Sequence Number: 16564502
• Product Code: POE
• UDI-Device Identifier: 05050474579187
• UDI-Public: (01)05050474579187(17)220124
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2020
• 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: 01/24/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 10/24/2018; 10/25/2020
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 11/13/2018; 11/03/2020
• 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: 51 YR
• Date Report Sent to FDA: 01/01/2005