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

Model Number	ZXT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Date of Event	06/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's right eye due to the patient complaining of unwanted visual images and the lens was not what the patient was expecting.The patient was unhappy with distance and near vision.The replacement lens was a different model and higher diopter.There was no patient injury and no additional medical or surgical intervention required.The patient is stable.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no other complaints for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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 (b)(4) and capa-010215.
Additional Manufacturer Narrative
Additional information was received, and the following fields were updated accordingly: section d-10: device available for evaluation: yes.Section d-10: returned to manufacturer on: 10/12/2020.Section h-3: device returned to manufacturer: yes.Device evaluation: the complaint lens was received in a specimen cup.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, and that the lens was received cut in half with pieces of the lens missing, which is consistent with a lens handled during explant.Based on the return 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.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.

• 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: 10274396
• Report Number: 2648035-2020-00502
• Device Sequence Number: 19094133
• Product Code: POE
• UDI-Device Identifier: 05050474605763
• UDI-Public: (01)05050474605763(17)240121
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/16/2020
• 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: 01/21/2024
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/14/2020; 10/19/2020; 10/25/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/06/2020; 11/13/2020; 11/16/2020
• 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: 73 YR
• Date Report Sent to FDA: 01/01/2005