MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS SYMFONY; MULTIFOCAL 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
Date of event: unknown as information was not provided.The best estimate date is between (b)(6) 2019 and (b)(6) 2020.(b)(4).Attempts were made to contact the customer account requesting additional information however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported zxr00 intraocular lens (iol) was implanted in the patient¿s ocular sinister (left eye) on (b)(6) 2019.The zxr00 19.0 diopter lens was explanted on (b)(6) 2020 due to complaints of incorrect lens power/for power.There was no patient injury, no suture(s), and no vitrectomy however the incision was enlarged.Attempts were made to contact the customer account requesting additional information however, to date no response has been received.No additional information was provided.
Additional Manufacturer Narrative
Additional information was received, and the following fields were updated accordingly.Section d-10: device available for evaluation: yes.Section d-10: returned to manufacturer on: 3/31/2020.Section h-3 device returned to manufacturer: yes.Device evaluation: the lens was received wrapped in gauze.Additionally, a hard copy email with complaint details was received.Visual inspection under magnification revealed fibers on the lens, which can be attributes to receiving the lens wrapped in gauze.Additionally, a detached haptic was observed.The haptic looks like it was cut during the explant process (area of detachment) and not related to a manufacturing issue.The complaint issue could not be confirmed, and no product deficiency was identified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no other complaints for this production order number have been received.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.H3 other text : placeholder.
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 (b)(4).

• 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: 9949394
• Report Number: 2020664-2020-00029
• Device Sequence Number: 16961818
• Product Code: POE
• UDI-Device Identifier: 05050474579071
• UDI-Public: (01)05050474579071(17)230820
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2020
• 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: 08/20/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 04/12/2020; 10/25/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 04/14/2020; 10/30/2020
• 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