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

Model Number	ZXT375
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Vitreous Floaters (1866)
Date of Event	05/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned as it remains implanted.The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed no other complaints has been received for this production order number.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 and johnson surgical vision has been submitted.
Event or Problem Description
It was reported for a study subject that tecnis intraocular lens was implanted in patient¿s right eye and the lens was placed at axis 010.Reportedly ,there was axis misalignment of 13 degrees with tecnis toric intraocular lens observed at 6-month visit with reported axis placement of 177 in patient¿s right eye.There are no plans for secondary surgical intervention.Additional information was received, and it was learned that patient was experiencing non-directed visual symptoms like floaters in the right eye.No visual symptoms reported.Subject has exited the study and is happy.Pre-op best corrective visual acuity (bcva): 20/25 ¿ right eye.Pre-op best corrective visual acuity: 20/30 ¿ left eye.At 6-month visit uncorrected distance visual acuity (ucdva): 20/20 ¿ both eyes.Best corrective distance visual acuity: 20/20 ¿ both eyes no further information provided.
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.
Additional Manufacturer Narrative
Corrected data: on further review of this event it was noticed that section d7 was inadvertently not addressed in the initial mdr.Section d7: if explanted, give date: not applicable, remains implanted in the eye.All pertinent information available to johnson and johnson surgical vision has been submitted.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10148906
• Report Number: 9614546-2020-00223
• Device Sequence Number: 19393374
• Product Code: POE
• UDI-Device Identifier: 05050474606999
• UDI-Public: (01)05050474606999(17)231031
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2020
• 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: 10/31/2023
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U210
• 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: 05/21/2020
• Supplement Date Received by Manufacturer: 06/29/2020; 10/25/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 07/24/2020; 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Date Report Sent to FDA: 01/01/2005