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
If implanted; give date: the implant date provided ((b)(6) 2017) is after the reported explant date.Clarification has been requested regarding the implant date however a response has not yet been received.(b)(4).An attempt has been made to obtain missing 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 that a model zxr00 intraocular lens (iol) was explanted from the patient's left eye.No additional information was provided to johnson & johnson surgical vision, inc.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found related to the complaint issue reported.There was no discrepancy found during the review.The product was manufactured and released according to the specifications.A search revealed that no similar complaints were received from this production order.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correct data: in the initial report 9614546-2018-00206, if implanted; give date: it was incorrectly not populated.(b)(6) 2017 should have been entered.The intraocular lens zxr00 +16.0 diopter was explanted on (b)(6) 2018 and replaced with a zmb00 +15.5 diopter.The correct implant date of (b)(6) 2018 has been updated/corrected accordingly.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
• MDR Report Key: 7308772
• Report Number: 9614546-2018-00206
• Device Sequence Number: 1276613
• Product Code: POE
• UDI-Device Identifier: 05050474579019
• UDI-Public: (01)05050474579019(17)220716
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2018

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: 07/16/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0160
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 04/13/2018; 05/21/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 05/12/2018; 06/18/2018
• 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