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	Red Eye(s) (2038); Blurred Vision (2137); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, not provided date of event: unknown, not provided.Best estimate (b)(6) 2019.(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted due to blurry vision where the patient reported feeling uncomfortable.The lens was replaced with a same model, same diopter lens.The patient was reported doing good, no issues post-op.No further information was provided.
Additional Manufacturer Narrative
Corrected data: in review of the initial mdr, it was noted that in section 'event description', the data reported was in error.The replacement lens was actually a model pcb00 lens, not the same model lens as was explanted.Device available for evaluation; returned to manufacturer on 08/15/2019.Device evaluation: the complaint was received on 08/15/2019 in a specimen container.The lens is cut in two pieces most probably related to the explant of the lens.The lens edges are smooth except for the lens cut area.Both haptics are complete, the haptic tips are properly polished.There was no lens problem reported by customer to confirm a complaint.Based on the product returned and information provided there is no indication of a product quality deficiency.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints were received for this production order number.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: 8867521
• Report Number: 2648035-2019-00855
• Device Sequence Number: 2389892
• Product Code: POE
• UDI-Device Identifier: 05050474606999
• UDI-Public: (01)05050474606999(17)240111
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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): 11/11/2020
• 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: 01/11/2024
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 08/23/2019; 10/25/2020
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 08/23/2019; 11/12/2020
• 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