MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS SYMFONY; MONOFOCAL 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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zxr00 20.5 diopter intraocular lens was explanted on (b)(6) 2018 from a patient who has fuchs dystrophy.Reportedly, the doctor believes the issue as he sees it is that the patient has fuchs dystrophy.Also, the patient's implanted lens was implanted by a different doctor than the one that's going to explant the lens.The replacement lens was a pcb00 24.0 diopter lens and the patient is doing well and is very happy with vision that is much better as far as glare/halo.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.Labeling review: the labeling review was not reviewed because limited information was received.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
Correction: in review, the catalog number, serial number, and udi were incorrectly reported.The correct catalog number is zxr00u0240, the correct serial number is (b)(4), and the correct udi is (b)(4).Additional information: additional information received reported the patient is a male with the right eye being the operative eye, initials are w.C., and date of birth 04/02/1940.Also, the implant date was (b)(6) 2017 and the explant date was (b)(6) 2018.The replacement lens was the same model (zcb00), but different diopter of 24.0.In addition, the reason for the explant was because the patient had fuch''s dystrophy.No additional information was provided.Age/date of birth: (b)(6) 1940.Gender/sex: male.Catalog number: zxr00u0240.Udi number: (b)(4).Serial number: (b)(4).If implanted, give date: (b)(6) 2017.Patient code 3191 ¿ fuch''s dystrophy.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SYMFONY
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7453011
• Report Number: 9614546-2018-00375
• Device Sequence Number: 1195757
• Product Code: HQL
• UDI-Device Identifier: 05050474605800
• UDI-Public: (01)05050474605800(17)211017
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2018
• 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: Physician
• Device Expiration Date: 10/17/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 05/18/2018; 07/09/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 06/11/2018; 07/12/2018
• 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