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

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that zxt150 17.5 lens was explanted from patient's affected eye and replaced with zxt150 18.5 lens.The reason of explant is due to blurry vision.It was noted that there was no patient injury and there was no wound enlargement during explant.Patient's vision has improved.No additional information provided.
Additional Manufacturer Narrative
In the initial mdr, reason for non-evaluation - was inadvertently not populated."device evaluation anticipated but not yet begun" should have been selected.The product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.The manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Based on the investigation results there is no indication of a product quality deficiency.
Additional Manufacturer Narrative
Corrected data: in review of follow-up report #2, date rec'd by mfr was incorrectly reported as 1/9/2018.The correct date should have been reported as 1/9/2019.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: device available for evaluation ¿ yes, returned to manufacturer on 08/01/2018.Device returned to manufacturer ¿ yes.Device evaluation: the product was received in a zip lock bag.The product was disinfected according to procedure but the lens was lost after the decontamination step.Considering the condition of no lens available, additional analysis is not possible.An investigation was opened to further investigate this issue.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: 7684213
• Report Number: 9614546-2018-00672
• Device Sequence Number: 1554319
• Product Code: POE
• UDI-Device Identifier: 05050474605152
• UDI-Public: (01)05050474605152(17)220619
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• 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,Followup,Followup
• Report Date (Section B): 10/30/2020
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 11/16/2018; 01/09/2018; 02/27/2019; 10/25/2020
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 12/13/2018; 01/31/2019; 02/28/2019; 10/30/2020
• 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