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

Model Number	ZXT375
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Date of event: exact date not provided, best estimate is between (b)(6) 2019 ¿ (b)(6) 2019.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specifications.A search in the complaint system revealed that no similar complaints were received for 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.
Event or Problem Description
It was reported that a former study patient underwent explant of a model zxt375 20.0 diopter intraocular lens (iol), from the right eye (od) due to halos and glare causing difficulty with driving at night.The explant/exchange was conducted after the patient exited the study.The replacement lens was a model zct300 20.0 diopter.The patient is noted to be recovering.The explanted lens was discarded and is unavailable for return.No further information was provided.
Additional Manufacturer Narrative
Section d10.Device available for evaluation? yes; returned to manufacturer on: 10/23/2019 section h3.Device returned to manufacturer? yes.Device evaluation: the product was received at the manufacturing site for evaluation in a lens case.The lens was inspected using a 12x magnification microscope.It can be seen that the lens is contaminated, dust particles are present.This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmental controlled area.The lens is damaged most likely to make the explant possible.No further anomalies were found.The complaint cannot be confirmed.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: 9159304
• Report Number: 9614546-2019-00946
• Device Sequence Number: 2430291
• Product Code: POE
• UDI-Device Identifier: 05050474606975
• UDI-Public: (01)05050474606975(17)210717
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2020
• 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: 07/17/2021
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 11/12/2019; 10/25/2020
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 12/09/2019; 11/10/2020
• 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
• Date Report Sent to FDA: 01/01/2005