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	Halo (2227); No Code Available (3191)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If explanted, give date: not applicable, as lens remains implanted.The device is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.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 a patient bilateral intraocular lens (iol) implants, but she can¿t see up close, intermediate items, sees halos and can¿t drive at night.It was learned that she also has glares.The patient is so upset because her visual concerns have been going on since around the beginning of implanting of the intraocular lenses (iols) until now.The patient claims that the symptoms significantly interfere with her regular activities.She found another doctor who explanted her iol from her right eye (od).The doctor wants to wait so see how the patient does before potentially explanting the lens in the other eye.No other information was provided.This mdr report pertains to the left eye (os).A separate report will be submitted for the od.
Additional Manufacturer Narrative
Corrected data: upon further review, it was observed that in follow-up report #1 mfr report number 9614546-2020-00236 section d10: returned to manufacturer on date was inadvertently populated with the date 8/26/2020.The correct date the device was returned to manufacturer is 8/28/2020.As a result, section d10 has been updated accordingly.Section d10: returned to manufacturer on: 8/28/2020.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: further follow-up confirmed that suspect product was explanted on (b)(6) 2020 and replaced with model za9003 15.5 diopter lens.No issues or injury occurred during the case.Section d7 was updated from not applicable to 8/3/2020.Section d10.Device available for evaluation? yes.Returned to manufacturer on: 8/26/2020.Section h3.Device returned to manufacturer? yes.Device evaluation: the complaint lens was received in a specimen cup.A shipping label was received as well.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, and that the lens was received cut (but not separated), which is consistent with a lens that was handled during explant.Based on the return condition of the lens, no further product evaluation via visual inspection could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.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.
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 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: 10202310
• Report Number: 9614546-2020-00236
• Device Sequence Number: 13721242
• Product Code: POE
• UDI-Device Identifier: 05050474605701
• UDI-Public: (01)05050474605701(17)211026
• Combination Product (Y/N): Y
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 10/26/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• 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: 08/03/2020; 09/01/2020; 10/25/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 08/31/2020; 09/23/2020; 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: Other
• Patient Age: 61 YR
• Date Report Sent to FDA: 01/01/2005