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

Model Number	ZXR00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/ date of birth: unknown, information not provided.Implant date: not applicable as lens was removed/ replaced in the initial surgery.Explant date: not applicable as lens was removed/ replaced in the initial surgery.(b)(4).
Event or Problem Description
It was reported that after inserting the intraocular lens (iol) into the patient¿s left eye, a crack was observed on the iol.The iol was removed and replaced within the same procedure.The incision was slightly enlarged approximately 5mm.One suture was used.There was no patient injury reported and the patient postop is 20/20+1.But he does not see as well as he wanted to up close.He¿s at j13.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed as the product was not returned.The reported event could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no other complaints have been received for this production order.Conclusion: based on the investigation results no product deficiency was identified.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.

• Brand Name: TECNIS SYMFONY
• 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: 10107562
• Report Number: 2648035-2020-00430
• Device Sequence Number: 3156024
• Product Code: POE
• UDI-Device Identifier: 05050474591745
• UDI-Public: (01)05050474591745(17)230816
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 07/01/2020; 10/25/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 07/28/2020; 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: Required Intervention
• Date Report Sent to FDA: 01/01/2005