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

Model Number	ZXT300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of birth/age: unknown, information not provided.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported zxt300 19.0 diopter intraocular lens (iol) was implanted in the patient¿s operative eye on (b)(6) 2019.The lens was explanted on (b)(6) 2019 due to complaint of hyperopia.It was reported there was no required medical intervention, the zxt300 19.0 diopter iol was replaced with a zxt300 21.5 (larger) diopter lens, and patient was reported as well.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional information date of birth/age: (b)(6) 1950.Date of event: was updated to (b)(6) 2019.Additional information received: through follow up, customer provided additional information confirming reported hyperopia issues was first observed (b)(6) 2019 and confirmed reported hyperopia issues affect normal daily activities but are not debilitating.Device available for evaluation: yes.Returned to manufacturer on: 07/02/2019.Device evaluated by manufacturer: yes.Device evaluation: the product was received in a little jar with liquid.The product was disinfected according to procedure.The product is inspected by a qualified inspector using a microscope with a 12x magnification.It can be seen that the optic body has been damaged on both sides and a mark of the forcep is visible.Investigation of the return sample and the condition of the return sample do not suggest the damage was introduced during manufacturing.The complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no similar complaints for this order number have been received.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.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-(b)(4) and capa-010215.

• 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: 8729302
• Report Number: 9614546-2019-00575
• Device Sequence Number: 13885429
• Product Code: POE
• UDI-Device Identifier: 05050474606364
• UDI-Public: (01)05050474606364(17)210825
• 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
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020
• 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: 08/25/2021
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 06/27/2019; 10/25/2020
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 07/23/2019; 11/13/2020
• 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: 68 YR
• Date Report Sent to FDA: 01/01/2005