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: exact date unknown/not provided, best estimate between (b)(6) 2017 - (b)(6) 2018.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that patient had refractive surprise/hyperopic miss after the implantation of model zxr00 16.5 diopter iol (intraocular lens) in her left eye (os).The patient continued to complain so an explant was planned.Through follow-up it was learnt the lens was explanted as planned and exchanged for another zxr00 of a higher diopter (18.0).There was no incision enlargement, vitrectomy, or sutures required.The patient was reported to be stable post exchange.No additional information provided.
Additional Manufacturer Narrative
The internal non-conformance numbers for this software issue are (b)(4) and capa-(b)(4).
Additional Manufacturer Narrative
Device evaluation: the device was not returned at 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 device were reviewed and there were no non-conformances with respect to the manufacturing process.The product was manufactured and released according to specification.Historical data analysis: a search in the complaints history revealed that no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.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 and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SYMFONY
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 8198052
• Report Number: 9614546-2018-01197
• Device Sequence Number: 252609
• Product Code: POE
• UDI-Device Identifier: 05050474579026
• UDI-Public: (01)05050474579026(17)211028
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2020
• 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: 10/28/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0165
• 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: 11/27/2018
• Supplement Date Received by Manufacturer: 01/07/2019; 10/25/2020
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 01/15/2019; 11/06/2020
• 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