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

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that lens was explanted from patient¿s left eye in secondary surgical procedure.There was no patient injury, no sutures and no vitrectomy requited.Additional information was received and it was learnt that the lens was explanted because the patient was unable to achieve good quality near vision with the lens.Reportedly lens with a different model, zlb00 and higher diopter of +22.5 was used as replacement for the patient.Patient is stable.No further information provided.
Additional Manufacturer Narrative
Additional information: section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: 6/23/2020.Section h3: device returned to manufacturer: yes.Device evaluation: the product was returned.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, which is consistent with a lens that was explanted.The lens was cleaned, and no cosmetic defects were observed.The complaint issue was not confirmed, and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.The search revealed that no other complaints have 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 & johnson surgical vision, inc.Has been submitted.H3 other text : placeholder.
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
• 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: 10198760
• Report Number: 9614546-2020-00234
• Device Sequence Number: 1072371
• Product Code: POE
• UDI-Device Identifier: 05050474579125
• UDI-Public: (01)05050474579125(17)230706
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 07/02/2020; 10/25/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 07/28/2020; 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005