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

Model Number	ZXT300
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Gender/sex: unknown, information not provided.If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that there were anterior deposits on lens observed while inserting lens into the patient's right eye.The lens was removed and replaced with another lens of the same model and diopter in the same surgical procedure.There was no incision enlargement required.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
Additional information: additional information was received and it was indicated that the lens had imperfections.Section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: (b)(6)2020.Section h3: device returned to manufacturer: yes.Device evaluation: the product was returned.Visual inspection under magnification revealed that the lens was received cut in pieces, which is consistent with a lens that was handled during explant.The lens was cleaned, and no inclusions were observed.Based on the returned condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.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 were 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 & johnson surgical vision, inc.Has been submitted.H3 other text : placeholder.

• 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: 10077584
• Report Number: 9614546-2020-00206
• Device Sequence Number: 19800091
• Product Code: POE
• UDI-Device Identifier: 05050474606302
• UDI-Public: (01)05050474606302(17)230316
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/16/2023
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 06/08/2020; 10/25/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 07/06/2020; 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC30 CARTRIDGE LOT# UNKNOWN.
• Patient Age: 54 YR
• Date Report Sent to FDA: 01/01/2005